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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
Applicant
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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