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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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