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 K893981
Device Name WATCHCHILD
Applicant
Monox, Inc.
10572 Calle Lee
Suite 122
Los Alamitos,  CA  90720
Applicant Contact THEODORE TREMPER
Correspondent
Monox, Inc.
10572 Calle Lee
Suite 122
Los Alamitos,  CA  90720
Correspondent Contact THEODORE TREMPER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/02/1989
Decision Date 04/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-