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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K854840
Device Name PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
Original Applicant
11 business park dr.
branford,  CT  06405
Original Contact richard a mentelos
Regulation Number870.2340
Classification Product Code
Date Received12/04/1985
Decision Date 05/07/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No