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 K850395
Device Name THE FEVER-THERM A THERM. MEASURING DEVICE
Applicant
Kma, Inc.
4711 Overbrook Rd.
Bethesda,  MD  20816
Applicant Contact MARY SHIVANANDAN
Correspondent
Kma, Inc.
4711 Overbrook Rd.
Bethesda,  MD  20816
Correspondent Contact MARY SHIVANANDAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/01/1985
Decision Date 08/13/1985
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
-
-