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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
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact RICHARD A MENTELOS
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact RICHARD A MENTELOS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/04/1985
Decision Date 05/07/1986
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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