PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2025-06-11
PERIGEN SOLUTIONS LTD
GUDID#
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2025-06-11
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2025-06-11
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2024-10-08
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2024-10-08
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2024-10-08
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2024-04-17
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2024-04-17
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2024-04-17
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2023-12-27
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2023-12-27
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2023-12-27
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2022-09-04
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2022-09-04
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2022-09-04
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2021-07-21
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2021-07-21
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2021-07-21
PeriWatch Vigilance® Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
2020-08-11
PeriWatch Vigilance® HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2020-08-11
PeriWatch Vigilance® Cues™ - PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2020-08-11
PeriCALM® Curve™ - PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
2016-05-30
PeriWatch™ Curve™ - PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
2017-06-22
PeriWatch™ Vigilance™ Curve™ - PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
2018-11-12
PeriCALM® Curve™ - PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
2017-12-18
PeriCALM® Tracings™, HUB Module - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2017-07-09
PeriWatch™ HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2017-12-18
PeriWatch™ HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2018-09-16
PeriWatch™ Vigilance™ HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2018-11-12
PeriWatch® Curve™ - PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
2019-03-06
PeriCALM® Tracings™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2016-05-30
PeriWatch™ Vigilance™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2018-11-12
PeriWatch Vigilance™ HUB™ - PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
2019-06-04
PeriWatch® Cues™ - PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2019-03-06
PeriCALM® CheckList™ - PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2016-05-30
PeriCALM® Patterns™ - PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2016-05-30
PeriCALM® Patterns™ - PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2017-11-27
PeriCALM® Patterns™ - PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2016-05-30
PeriWatch™ Cues™ - PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2017-06-22
PeriWatch™ Vigilance™ Cues™ - PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
2018-11-12