PMX COMPACT RESUCITATOR


Device Classification Name

ventilator, emergency, manual (resuscitator)

510(k) Number K021390
Device Name PMX COMPACT RESUCITATOR
Original Applicant
CHEEN HOUNG ENT. CO. LTD.
23 san dreen st., alley 11,
lane 65
taipei (shulin), 

TW

23805

Original Contact jay wang
Regulation Number 868.5915
Classification Product Code
BTM  
Date Received 05/02/2002
Decision Date 10/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No