510(k) K801553
K801553 is an FDA 510(k) premarket notification submitted by Hospital Financial Corp. for the device "THERMOCOMP". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1980
- Date Received
- July 8, 1980
- 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