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 Thermometer, Clinical Mercury
510(k) Number K913793
Device Name SIMPEX INC. ORAL AND RECTAL THERMOMETERS
Applicant
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Applicant Contact XI MEI
Correspondent
Simpex, Inc.
801 Old York Rd.
Suite 318
Jenkintown,  PA  19046
Correspondent Contact XI MEI
Regulation Number880.2920
Classification Product Code
FLK  
Date Received08/23/1991
Decision Date 12/30/1991
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
-
-