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FDA 510(k), K201418, Sunset Heated CPAP Tube
FDA 510(k), K201418, Sunset Heated CPAP Tube
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510(K) Number: K201418
Device Name: Sunset Heated CPAP Tube
Manufacturer: Sunset Healthcare Solutions, Inc.
Device Classification Name: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 05/29/2020
Decision Date: 01/29/2021
Regulation Medical Specialty: Anesthesiology
Device Name: Sunset Heated CPAP Tube
Manufacturer: Sunset Healthcare Solutions, Inc.
Device Classification Name: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 05/29/2020
Decision Date: 01/29/2021
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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