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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K861261
Device Name OHMEDA POSI-PULSE SUCTION UNIT
Applicant
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact DOUGLAS D CARDEN
Correspondent
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact DOUGLAS D CARDEN
Regulation Number880.6740
Classification Product Code
GCX  
Date Received04/04/1986
Decision Date 05/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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