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 K121208
Device Name OBIX PERINATAL DATA SYSTEM 7.0
Applicant
CLINICAL COMPUTER SYSTEMS, INC.
715 TOLLGATE RD.
UNIT H
elgin,  IL  60123 -9331
Applicant Contact cynthia bell
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
twinsburg,  OH  44087
Correspondent Contact william sammons
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/20/2012
Decision Date 06/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-