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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K903625
Device Name DOPPLER NEEDLE AND FLOW MONITOR
Applicant
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact JESSICA AYRES
Correspondent
Peripheral Systems Group
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact JESSICA AYRES
Regulation Number870.2100
Classification Product Code
DPW  
Date Received08/10/1990
Decision Date 11/07/1990
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
Recalls CDRH Recalls
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