510(k) K032471
K032471 is an FDA 510(k) premarket notification submitted by Titronics Research & Development Co. for the device "TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 10, 2003. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Titronics Research & Development Co. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 10, 2003
- Date Received
- Aug 11, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Telethermographic (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type
- 510(k)