510(k) K813547
K813547 is an FDA 510(k) premarket notification submitted by Bcd Products, Inc. for the device "THERMASCAN". The FDA issued a decision of Substantially Equivalent on March 12, 1982. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982. Bcd Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1982
- Date Received
- December 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- Device Class
- Class III
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type