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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K001775
Device Name ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
Applicant
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Applicant Contact PAUL M FITZMEYER
Correspondent
ZOE MEDICAL, INC.
460 BOSTON ST.
TOPSFIELD,  MA  01983 -1223
Correspondent Contact PAUL M FITZMEYER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/12/2000
Decision Date 01/12/2001
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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