MULTI-STRAP FULL FACE MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K023683
Device Name MULTI-STRAP FULL FACE MASK
Original Applicant
ENGINEERED MEDICAL SYSTEMS
6329 w. waterview ct.
mccordsville, 
IN 
46055

Original Contact paul dryden
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 11/01/2002
Decision Date 12/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No