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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, Powered (Resuscitator)
510(k) Number K841893
Device Name MAXAMAN
Applicant
CRYO2 CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CRYO2 CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/07/1984
Decision Date 08/30/1984
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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