FDA 510(k), K203215, Radius T wearable thermometer
FDA 510(k), K203215, Radius T wearable thermometer
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510(K) Number: K203215
Device Name: Radius T wearable thermometer
Manufacturer: Masimo Corporation
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 11/02/2020
Decision Date: 06/11/2021
Regulation Medical Specialty: General Hospital
Device Name: Radius T wearable thermometer
Manufacturer: Masimo Corporation
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 11/02/2020
Decision Date: 06/11/2021
Regulation Medical Specialty: General Hospital
- 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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