Device Classification Name |
laryngoscope, rigid
|
510(k) Number |
K941319 |
Device Name |
THE WUSCOPE SYSTEM |
Applicant |
ACHI CORP. |
1522 BLACKFOOT DR. |
P.O. BOX 3282 |
FREMONT,
CA
94539
|
|
Applicant Contact |
HSIU C CHOU,M.D. |
Correspondent |
ACHI CORP. |
1522 BLACKFOOT DR. |
P.O. BOX 3282 |
FREMONT,
CA
94539
|
|
Correspondent Contact |
HSIU C CHOU,M.D. |
Regulation Number | 868.5540
|
Classification Product Code |
|
Date Received | 03/18/1994 |
Decision Date | 10/04/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|