Transmitters And Receivers, Physiological Signal, Radiofrequency

Product Code: DRG

Cardiovascular Microwave Medical Products

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2910


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as DRG

747Transmitters And Receivers, Physiological Signal, RadiofrequencyRadiofrequency Physiological Signal Transmitter And Receiver.

Total Product Life Cycle (TPLC) Devices

747Transmitters And Receivers, Physiological Signal, RadiofrequencyRadiofrequency Physiological Signal Transmitter And Receiver.

Pre-market Notifications for DRG

K213233EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co.,Ltd.
K212883Ers2 - Ergoline Rehabilitation SystemErgoline GmbH
K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated
K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio
K211305ANNE OneSibel Inc.
K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifeSignals, Inc.
K200690LifeSignals ECG Remote Monitoring Patch PlatformLifeSignals, Inc.
K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)VitalConnect, Inc.
K192875Philips Biosensor BX100Philips Medical Systems
K192757VitalPatch 5D Biosensor - Single, VitalPatch 7D Biosensor - Single, VitalPatch 5D Biosensor – Bag Of 20, VitalPatch 7D Biosensor – Bag Of 20VitalConnect, Inc.
K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.
K191614BioSticker SystemBioIntelliSense Inc.
K191620Vitls PlatformVitls Inc.
K191331Life Sensor Cardiac MonitorBraveHeart Wireless, Inc.
K190916VitalPatch 7D Biosensor - Single, VitalPatch 7D Biosensor - Bag Of 20VitalConnect, Inc.

Global Unique Device Identification Database

00643169838451TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
00707387766597TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
00763000001964TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
00812345027419Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345027402Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345027396Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345027389Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345027037Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345026009Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025996Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025989Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025972Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025965Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025958Transmitters And Receivers, Physiological Signal, Radiofrequency
00812345025941Transmitters And Receivers, Physiological Signal, Radiofrequency

Maude Adverse Events

VITAL SYNC REMOTE MONITORING SYSTEMAVNET INC2020-03-30
ORG-9110ANIHON KOHDEN CORPORATION2020-03-29
ORG-9110ANIHON KOHDEN CORPORATION2020-03-14
ORG-9110ANIHON KOHDEN CORPORATION2020-03-06
ORG-9110ANIHON KOHDEN CORPORATION2020-03-02
ORG-9110ANIHON KOHDEN CORPORATION2020-03-02
ORG-9110ANIHON KOHDEN CORPORATION2020-03-02
ORG-9110ANIHON KOHDEN CORPORATION2020-02-27
CENTRAL MONITORING SYSTEMNKUS LAB2020-02-21
ORG-9110ANIHON KOHDEN CORPORATION2020-02-21
ECARECOMPANIONVISICU, INC - DUP2020-02-19
ORG-9100ANIHON KOHDEN CORPORATION2020-02-11
ORG-9100ANIHON KOHDEN CORPORATION2020-02-11
ORG-9110ANIHON KOHDEN CORPORATION2020-02-07
VITAL SYNC REMOTE MONITORING SYSTEMAVNET INC2020-02-07
ORG-9110ANIHON KOHDEN CORPORATION2020-01-27
ORG-9110ANIHON KOHDEN CORPORATION2020-01-24
NANAPHILIPS MEDICAL SYSTEMS2020-01-24
ORG-9110ANIHON KOHDEN CORPORATION2020-01-17
ORG-9100ANIHON KOHDEN CORPORATION2020-01-08
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-10-30
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-10-23
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-10-22
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-10-21
ORG-9100ANIHON KOHDEN CORPORATION2019-10-18
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-10-18
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-10-07
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-09-27
ORG-9110ANIHON KOHDEN CORPORATION2019-09-25
ORG-9110ANIHON KOHDEN CORPORATION2019-09-23
ORG-9110ANIHON KOHDEN CORPORATION2019-09-18
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-08-28
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-08-27
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-08-27
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-08-16
GZ-140PANIHON KOHDEN CORPORATION2019-08-14
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-08-06
ORG-9110ANIHON KOHDEN CORPORATION2019-07-25
WI-FI SERIESST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-07-18
ORG-9100ANIHON KOHDEN CORPORATION2019-07-17
ORG-9110ANIHON KOHDEN CORPORATION2019-07-12
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SYLMAR)2019-07-12
MERLIN@HOME, RF TELEMETRY BASICABBOTT CRM2019-07-11
ORG-9100ANIHON KOHDEN CORPORATION2019-07-05
MERLIN@HOME, RF TELEMETRY BASICABBOTT2019-07-03
ZM-920PANIHON KOHDEN CORPORATION2019-07-02
ORG-9100ANIHON KOHDEN CORPORATION2019-07-02
MERLIN@HOME, RF TELEMETRY BASICST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-06-27
ORG-9110ANIHON KOHDEN CORPORATION2019-06-20
ORG-9110ANIHON KOHDEN CORPORATION2019-06-19
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