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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Computer, Blood-Pressure
510(k) Number K893232
Device Name MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
Applicant
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact HAZEL SHUMWAY
Correspondent
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact HAZEL SHUMWAY
Regulation Number870.1110
Classification Product Code
DSK  
Date Received04/28/1989
Decision Date 07/14/1989
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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