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 Continuous Measurement Thermometer
510(k) Number K922344
Device Name OMRON TYMPANIC THERMOMETER MC-500
Applicant
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Applicant Contact LEE A CABOT
Correspondent
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact LEE A CABOT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/19/1992
Decision Date 06/29/1993
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
-
-