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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K840865
Device Name INFANT STAR VENTILATOR
Applicant
INFRASONICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INFRASONICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/27/1984
Decision Date 04/30/1984
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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