510(k) K982965

ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES by Richard Wolf Medical Instruments Corp. — Product Code FWF

K982965 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 23, 1998. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1998
Date Received
August 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Endoscopic, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type