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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Ventilator, Home Use
510(k) Number K034032
Device Name PLV CONTINUUM VENTILATOR, MODEL P2000
Applicant
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92009
Applicant Contact MARY FUNK
Correspondent
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad,  CA  92009
Correspondent Contact MARY FUNK
Regulation Number868.5895
Classification Product Code
NOU  
Subsequent Product Code
CBK  
Date Received12/29/2003
Decision Date 03/16/2004
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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