Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K942141 |
Device Name |
EIDOLON ENDOSCOPE COUPLER |
Applicant |
EIDOLON CORP. |
3 ERIE DR. |
NATICK,
MA
01760
|
|
Applicant Contact |
VICTOR J DOHERTY |
Correspondent |
EIDOLON CORP. |
3 ERIE DR. |
NATICK,
MA
01760
|
|
Correspondent Contact |
VICTOR J DOHERTY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/03/1994 |
Decision Date | 05/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|