SIMPLIFY COMPACT RESUSCITATOR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K021716
Device Name SIMPLIFY COMPACT RESUSCITATOR
Original Applicant
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
unit b,1-5 f,warehouse & proc.
complex bldg. xiangyu f.t.z.
xiamen, 

CN

Original Contact shan hua ying
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 05/23/2002
Decision Date 10/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No