510(k) K812799
K812799 is an FDA 510(k) premarket notification submitted by Dorex, Inc. for the device "DCATS". The FDA issued a decision of Substantially Equivalent on October 20, 1981. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980. Dorex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1981
- Date Received
- October 6, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic, Infrared
- Device Class
- Class III
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type