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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K873286
Device Name DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
Applicant
HOSPITAK, INC.
1144 ROUTE 109
LINDENHURST,  NY  11757
Applicant Contact WILLIAM J LACEY
Correspondent
HOSPITAK, INC.
1144 ROUTE 109
LINDENHURST,  NY  11757
Correspondent Contact WILLIAM J LACEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/17/1987
Decision Date 10/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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