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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K890876
Device Name BP-8800 BLOOD PRESSURE MONITOR
Applicant
Colin Medical Instruments Corp.
107g Corporate Blvd.
South Plainfield,  NJ  07080
Applicant Contact ALAN P SCHWARTZ
Correspondent
Colin Medical Instruments Corp.
107g Corporate Blvd.
South Plainfield,  NJ  07080
Correspondent Contact ALAN P SCHWARTZ
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/21/1989
Decision Date 06/22/1989
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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