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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K820393
Device Name ANESTHESIA VENTILATOR
Applicant
PURITAN BENNETT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PURITAN BENNETT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/11/1982
Decision Date 03/12/1982
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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