510(k) K820829

MEDICAM by M.P. Video, Inc. — Product Code FWB

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