MASS CASUALTY VENTILATOR, MODEL MCV100


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K080063
Device Name MASS CASUALTY VENTILATOR, MODEL MCV100
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

Correspodent Contact wayne karcher
Regulation Number 868.5925
Classification Product Code
BTL  
Date Received 01/10/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No