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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 K760930
Device Name BLOOD PRESSURE & PULSE CHECKER
Applicant
BIO MEGA DIAGNOSTIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO MEGA DIAGNOSTIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/29/1976
Decision Date 11/09/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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