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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K130740
Device Name NIGHTINGALE MONITORING SYSTEM
Applicant
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Applicant Contact JAMES CHICKERING
Correspondent
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Correspondent Contact JAMES CHICKERING
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/19/2013
Decision Date 07/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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