FDA.reportPublic FDA data

510(k) K873150

Device
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
Applicant
PEDIATRIC DIAGNOSTIC SERVICE
510(k) number
K873150
Product code
HFM  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-11
Date received
1987-08-11
Regulation
884.2720
Classification name
Monitor, Uterine Contraction, External (for Use In Clinic)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY KOEPSELL
Address
221 Third St. Cambridge MA US 02141 02141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140163KOALA TOCOClinical Innovations, LLC2014-05-29
K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.2006-07-12
K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.2004-09-14
K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.2000-03-22
K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.2000-01-18
K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.1996-05-22
K952579TOCO TRANSDUCERScientific Device Manufacturer, LLC1995-08-04
K920152BUBBLE TOCOUtah Medical Products, Inc.1993-05-26
K910282MEDI-TRACE(R) DISPOSABLE TOCOTONOMETERGraphic Controls Corp.1991-03-29
K904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTAir-Shields Vickers, Inc.1991-02-19
K903623MODEL600 UTERINE ACTIVITY MONITORCorometrics Medical Systems, Inc.1990-11-07
K902104ORION WATCHGUARDOrion Industries1990-10-25
K894030MODEL 37 UTERINE CONTRACTION ACTIVITY MONITORHealthdyne, Inc.1990-01-22
K893770TERM GUARD II DEVICETokos Medical Corp.1989-11-03
K891997CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCERCorometrics Medical Systems, Inc.1989-06-08

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases