The following data is part of a premarket notification filed by Titronics Research & Development Co. with the FDA for Tytron C-3000.
Device ID | K974208 |
510k Number | K974208 |
Device Name: | TYTRON C-3000 |
Classification | Device, Temperature Measurement, Direct Contact, Powered |
Applicant | TITRONICS RESEARCH & DEVELOPMENT CO. 2046 REDWING HOLLOW S.W. Oxford, IA 52322 |
Contact | Joseph R Titone |
Correspondent | Joseph R Titone TITRONICS RESEARCH & DEVELOPMENT CO. 2046 REDWING HOLLOW S.W. Oxford, IA 52322 |
Product Code | HCS |
CFR Regulation Number | 882.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-10 |
Decision Date | 1998-02-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860447001714 | K974208 | 000 |
00860447001707 | K974208 | 000 |