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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K833994
Device Name PULSAIR I & II
Applicant
CRYO CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CRYO CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received11/21/1983
Decision Date 12/12/1983
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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