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FDA 510(k)

Sunset Heated CPAP Tube

K-Number: K201418 · 2021-01-29

ApplicantSunset Healthcare Solutions, Inc.
Decision Date2021-01-29
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sunset Heated CPAP Tube is a medical device manufactured by Sunset Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2021-01-29 under approval number K201418. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunset Heated CPAP Tube?

Sunset Heated CPAP Tube is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Sunset Healthcare Solutions, Inc.. The 510(k) number is K201418.

When was Sunset Heated CPAP Tube approved by the FDA?

Sunset Heated CPAP Tube received FDA 510(k) clearance on 2021-01-29, under approval number K201418.

What company makes Sunset Heated CPAP Tube?

Sunset Heated CPAP Tube is manufactured by Sunset Healthcare Solutions, Inc..

What is the FDA product code for Sunset Heated CPAP Tube?

The FDA product code for Sunset Heated CPAP Tube is BZE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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