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 K070339
Device Name DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
Applicant
Cincinnati Sub-Zero Products, Inc.
1201 Mostellar Rd.
Cincinnati,  OH  45241
Applicant Contact DAN WITTMER
Correspondent
Cincinnati Sub-Zero Products, Inc.
1201 Mostellar Rd.
Cincinnati,  OH  45241
Correspondent Contact DAN WITTMER
Regulation Number880.2910
Classification Product Code
FLL  
Subsequent Product Code
BZT  
Date Received02/05/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-