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FDA 510(k)

BreathePal Bilevel (GFM50-MD2201)

K-Number: K252078 · 2026-03-17

ApplicantCompal Electronics, Inc.
Decision Date2026-03-17
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BreathePal Bilevel (GFM50-MD2201) is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K252078. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BreathePal Bilevel (GFM50-MD2201)?

BreathePal Bilevel (GFM50-MD2201) is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Compal Electronics, Inc.. The 510(k) number is K252078.

When did BreathePal Bilevel (GFM50-MD2201) receive FDA 510(k) clearance?

BreathePal Bilevel (GFM50-MD2201) received FDA 510(k) clearance on 2026-03-17, under 510(k) number K252078.

Who is the listed applicant for BreathePal Bilevel (GFM50-MD2201)?

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

What is the FDA product code for BreathePal Bilevel (GFM50-MD2201)?

The FDA product code for BreathePal Bilevel (GFM50-MD2201) is MNS. This falls under the Neurology category.

Other records listing Compal Electronics, Inc. as applicant

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Related Devices (Code: MNS)

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.

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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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