Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, monitoring, perinatal
510(k) Number K882084
Device Name GENESIS TM FETAL SYSTEM
Applicant
PEDIATRIC DIAGNOSTIC SERVICE
200 NORTH COBB PKWY.
SUITE 128
MARIETTA,  GA  30062
Applicant Contact DAVID SIMIC
Correspondent
PEDIATRIC DIAGNOSTIC SERVICE
200 NORTH COBB PKWY.
SUITE 128
MARIETTA,  GA  30062
Correspondent Contact DAVID SIMIC
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/18/1988
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-