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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
Predetermined Change
Control Plan Authorized		 No
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