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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K952292
Device Name PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
Applicant
Puritan Bennett Corp.
9728 Pflumm Rd.
P.O.Box 15915
Lenexa,  KS  66215
Applicant Contact C. MARSHALL SMITH
Correspondent
Puritan Bennett Corp.
9728 Pflumm Rd.
P.O.Box 15915
Lenexa,  KS  66215
Correspondent Contact C. MARSHALL SMITH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/16/1995
Decision Date 11/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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