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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 K895031
Device Name MODIFIED INFANT NASAL CANNULAE ASSEMBLY
Applicant
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Applicant Contact BERNARD ACKERMAN,PHD
Correspondent
ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD,  NJ  07016
Correspondent Contact BERNARD ACKERMAN,PHD
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/08/1989
Decision Date 10/30/1989
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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