FDA 510(k), K200160, 740 SafeSAT

FDA 510(k), K200160, 740 SafeSAT

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510(K) Number: K200160
Device Name: 740 SafeSAT
Manufacturer: Zoe Medical, Inc.
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 01/22/2020
Decision Date: 02/15/2021
Regulation Medical Specialty: Cardiovascular

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