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 a medical device manufactured by Compal Electronics, Inc.. It received FDA 510(k) clearance on 2026-03-17 under approval 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. It is manufactured by Compal Electronics, Inc.. The 510(k) number is K252078.
When was BreathePal Bilevel (GFM50-MD2201) approved by the FDA?
BreathePal Bilevel (GFM50-MD2201) received FDA 510(k) clearance on 2026-03-17, under approval number K252078.
What company makes BreathePal Bilevel (GFM50-MD2201)?
BreathePal Bilevel (GFM50-MD2201) is manufactured by Compal Electronics, Inc..
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 Devices by Compal Electronics, Inc.
Related Devices (Code: MNS)
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.