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FDA 510(k)

BIPAP FOCUS

K-Number: K053168 · 2006-01-04

ApplicantRespironics (Ireland) Limited
Decision Date2006-01-04
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP FOCUS is the device name listed in this FDA 510(k) record. The listed applicant is Respironics (Ireland) Limited. It received FDA 510(k) clearance on 2006-01-04 under 510(k) number K053168. 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 BIPAP FOCUS?

BIPAP FOCUS is a medical device that received FDA 510(k) clearance on 2006-01-04. The listed applicant is Respironics (Ireland) Limited. The 510(k) number is K053168.

When did BIPAP FOCUS receive FDA 510(k) clearance?

BIPAP FOCUS received FDA 510(k) clearance on 2006-01-04, under 510(k) number K053168.

Who is the listed applicant for BIPAP FOCUS?

The FDA 510(k) record lists Respironics (Ireland) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPAP FOCUS?

The FDA product code for BIPAP FOCUS is MNS. This falls under the Neurology category.

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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.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK213169BPAP SystemBMC Medical Co., Ltd.

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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