510(k) K884039

MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 by Medical Dynamics, Inc. — Product Code FWH

K884039 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code FWH (Camera, Cine, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
September 26, 1988
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