FDA 510(k)

A Breathing System (ABS)

K-Number: K233580 · 2024-08-01

Decision Date2024-08-01

Product CodeHCC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

A Breathing System (ABS) is the device name listed in this FDA 510(k) record. The listed applicant is Deepwell Dtx, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) 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. The listed applicant is Deepwell Dtx, Inc.. The 510(k) number is K233580.

When did A Breathing System (ABS) receive FDA 510(k) clearance?

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

Who is the listed applicant for A Breathing System (ABS)?

The FDA 510(k) record lists Deepwell Dtx, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: HCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.

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.