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 K014094
Device Name MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Applicant
Hill-Rom Manufacturing, Inc.
11000 Regency Pkwy.
West Tower, Suite 205
Cary,  NC  27511
Applicant Contact CINDY L CROSBY
Correspondent
Hill-Rom Manufacturing, Inc.
11000 Regency Pkwy.
West Tower, Suite 205
Cary,  NC  27511
Correspondent Contact CINDY L CROSBY
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/12/2001
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-