COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K021841
Device Name COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
Original Applicant
PNEU PAC, LTD.
smiths medical
n7 w22025 johnson road
waukesha, 
WI 
53186 -1856

Original Contact donald alexander
Regulation Number 868.5925
Classification Product Code
BTL  
Date Received 06/05/2002
Decision Date 07/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No