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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 K871398
Device Name CPU-1 INTENSIVE CARE VENTILATOR
Original Applicant
OHMEDA MEDICAL
9065 guilford rd.
columbia,  MD  21046
Original Contact alberto f profumo
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/07/1987
Decision Date 05/07/1987
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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