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FDA 510(k), K201977, TempTraq
FDA 510(k), K201977, TempTraq
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510(K) Number: K201977
Device Name: TempTraq
Manufacturer: Blue Spark Technologies Inc.
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 07/16/2020
Decision Date: 12/03/2020
Regulation Medical Specialty: General Hospital
Device Name: TempTraq
Manufacturer: Blue Spark Technologies Inc.
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: 880.2910
Classification Product Code: FLL
Date Received: 07/16/2020
Decision Date: 12/03/2020
Regulation Medical Specialty: General Hospital
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- 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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