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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K881155
Device Name MODEL BPS08 BLOOD PRESSURE MODULE
Applicant
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact TOM CANE
Correspondent
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact TOM CANE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/18/1988
Decision Date 07/28/1988
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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