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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K133222
Device Name SAAD PATIENT MONITOR (SPM)
Applicant
HANIN MEDICAL SERVICES CO. LTD
57 LAZY BROOK ROAD
MONROE,  CT  06468
Applicant Contact RAYMOND J KELLY
Correspondent
HANIN MEDICAL SERVICES CO. LTD
57 LAZY BROOK ROAD
MONROE,  CT  06468
Correspondent Contact RAYMOND J KELLY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/18/2013
Decision Date 08/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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