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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 K923590
Device Name 318A RESPIRATORY SUPPORT SYSTEM
Applicant
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Applicant Contact MARSHALL SMITH
Correspondent
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Correspondent Contact MARSHALL SMITH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/20/1992
Decision Date 04/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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