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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 K970139
Device Name MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
Applicant
Micro Weiss Electronics
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Micro Weiss Electronics
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/15/1997
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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