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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 K935784
Device Name PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM
Applicant
Puritan-Bennett
10800 Pflumm Rd.
Lenexa,  KS  66215
Applicant Contact C. MARSHALL SMITH
Correspondent
Puritan-Bennett
10800 Pflumm Rd.
Lenexa,  KS  66215
Correspondent Contact C. MARSHALL SMITH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/06/1993
Decision Date 07/13/1994
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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