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 device, temperature measurement, direct contact, powered
510(k) Number K974208
Device Name TYTRON C-3000
Applicant
TITRONICS RESEARCH & DEVELOPMENT CO.
2046 REDWING HOLLOW S.W.
OXFORD,  IA  52322
Applicant Contact JOSEPH R TITONE
Correspondent
TITRONICS RESEARCH & DEVELOPMENT CO.
2046 REDWING HOLLOW S.W.
OXFORD,  IA  52322
Correspondent Contact JOSEPH R TITONE
Regulation Number882.1570
Classification Product Code
HCS  
Date Received11/10/1997
Decision Date 02/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-