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 K965008
Device Name BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
Applicant
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/16/1996
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-