Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K083385 |
Device Name |
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B |
Applicant |
ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. |
ST. LOUIS,
MO
63110
|
|
Applicant Contact |
WAYNE KARCHER |
Correspondent |
ALLIED HEALTHCARE PRODUCTS, INC. |
1720 SUBLETTE AVE. |
ST. LOUIS,
MO
63110
|
|
Correspondent Contact |
WAYNE KARCHER |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 11/17/2008 |
Decision Date | 05/14/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|