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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 K200160
Device Name 740 SafeSAT
Zoe Medical, Inc.
460 Boston Street
Topsfield,  MA  01983
Applicant Contact Jim Chickering
Zoe Medical, Inc.
460 Boston Street
Topsfield,  MA  01983
Correspondent Contact Jim Chickering
Regulation Number870.2300
Classification Product Code
Date Received01/22/2020
Decision Date 02/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No