The following data is part of a premarket notification filed by Titronics Research & Development Co. with the FDA for Tytron C-500ir Clinical Infrared Imaging System.
| Device ID | K032471 |
| 510k Number | K032471 |
| Device Name: | TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM |
| Classification | System, Telethermographic (adjunctive Use) |
| 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 | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-10-10 |
| Summary: | summary |