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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 K911780
Device Name INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/22/1991
Decision Date 06/24/1991
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
Recalls CDRH Recalls
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