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 K934941
Device Name E-Z TEMP II
Applicant
Seven C'S, Inc.
P.O. Box 410494
St. Louis,  MO  63141
Applicant Contact LES NENDORF
Correspondent
Seven C'S, Inc.
P.O. Box 410494
St. Louis,  MO  63141
Correspondent Contact LES NENDORF
Regulation Number880.2200
Classification Product Code
KPD  
Date Received10/18/1993
Decision Date 07/27/1994
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
-
-