Device Classification Name |
camera, television, endoscopic, without audio
|
510(k) Number |
K982754 |
Device Name |
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) |
Applicant |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
P.O.B. 454 |
GINOT SHOMRON,
IL
44853
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
P.O.B. 454 |
GINOT SHOMRON,
IL
44853
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 878.4160
|
Classification Product Code |
|
Date Received | 08/06/1998 |
Decision Date | 01/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|