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FDA 510(k)

A Breathing System (ABS)

K-Number: K233580 · 2024-08-01

ApplicantDeepwell Dtx, Inc.
Decision Date2024-08-01
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

A Breathing System (ABS) is a medical device manufactured by Deepwell Dtx, Inc.. It received FDA 510(k) clearance on 2024-08-01 under approval number K233580. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A Breathing System (ABS)?

A Breathing System (ABS) is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Deepwell Dtx, Inc.. The 510(k) number is K233580.

When was A Breathing System (ABS) approved by the FDA?

A Breathing System (ABS) received FDA 510(k) clearance on 2024-08-01, under approval number K233580.

What company makes A Breathing System (ABS)?

A Breathing System (ABS) is manufactured by Deepwell Dtx, Inc..

What is the FDA product code for A Breathing System (ABS)?

The FDA product code for A Breathing System (ABS) is HCC.

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Official Source

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

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