Device Classification Name |
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
|
510(k) Number |
K894649 |
Device Name |
EMERSON 33-CR CHEST RESPIRATOR |
Applicant |
EMERSON INTL. CO. |
22 COTTAGE PARK AVE. |
CAMBRIDGE,
MA
02140
|
|
Applicant Contact |
GEORGE EMERSON |
Correspondent |
EMERSON INTL. CO. |
22 COTTAGE PARK AVE. |
CAMBRIDGE,
MA
02140
|
|
Correspondent Contact |
GEORGE EMERSON |
Regulation Number | 868.5935
|
Classification Product Code |
|
Date Received | 07/24/1989 |
Decision Date | 10/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|