510(k) K982754

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) by A.Stein - Regulatory Affairs Consulting — Product Code FWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1999
Date Received
August 6, 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