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FDA 510(k), K180474, TNI softFlow 50
FDA 510(k), K180474, TNI softFlow 50
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510(K) Number: K180474
Device Name: TNI softFlow 50
Manufacturer: TNI Medical AG
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 02/22/2018
Decision Date: 10/18/2018
Regulation Medical Specialty: Anesthesiology
Device Name: TNI softFlow 50
Manufacturer: TNI Medical AG
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 02/22/2018
Decision Date: 10/18/2018
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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