510(k) K823516
K823516 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "ESA CAMERA". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code FWH (Camera, Cine, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1982
- Date Received
- November 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Cine, Surgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type