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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K040090
Device Name COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
Applicant
Pneupac , Ltd.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
Pneupac , Ltd.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received01/16/2004
Decision Date 05/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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