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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K881291
Device Name AIR PLETHYSMOGRAPH MODEL APG-1000
Applicant
Aci Medical, Inc.
9249 Glenoaks Bl.
Sun Valley,  CA  91352
Applicant Contact ED ARKANS
Correspondent
Aci Medical, Inc.
9249 Glenoaks Bl.
Sun Valley,  CA  91352
Correspondent Contact ED ARKANS
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/28/1988
Decision Date 10/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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