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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 K822113
Device Name INSPIRAID VA-1 VENTILATOR
Applicant
INSPIR AID
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSPIR AID
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/19/1982
Decision Date 08/31/1982
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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