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 Strip, Temperature, Forehead, Liquid Crystal
510(k) Number K864853
Device Name OMNI THERM TEMPERATURE MONITOR
Applicant
Omni Therm, Inc.
7919 N. Broadway
St. Louis,  MO  63147
Applicant Contact DALE E WALTERS
Correspondent
Omni Therm, Inc.
7919 N. Broadway
St. Louis,  MO  63147
Correspondent Contact DALE E WALTERS
Regulation Number880.2200
Classification Product Code
KPD  
Date Received12/11/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-