510(k) K820829
K820829 is an FDA 510(k) premarket notification submitted by M.P. Video, Inc. for the device "MEDICAM". The FDA issued a decision of Substantially Equivalent on May 3, 1982. The device falls under product code FWB (Camera, Television, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. M.P. Video, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1982
- Date Received
- March 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Surgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type