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FDA 510(k)

BIPAP AUTOSV

K-Number: K090248 · 2009-03-04

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-03-04
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIPAP AUTOSV is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2009-03-04 under 510(k) number K090248. 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 AUTOSV?

BIPAP AUTOSV is a medical device that received FDA 510(k) clearance on 2009-03-04. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K090248.

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

BIPAP AUTOSV received FDA 510(k) clearance on 2009-03-04, under 510(k) number K090248.

Who is the listed applicant for BIPAP AUTOSV?

The FDA 510(k) record lists Respironics Inc., Sleep & Home Respiratory Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPAP AUTOSV?

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

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Other records listing Respironics Inc., Sleep & Home Respiratory Group as applicant

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.

K092835COMFORTGEL NASAL MASKK092648RESPIRONICS PERFORMAX SE TOTAL FACE MASKK090539BIPAP AUTOSV ADVANCEDK091191GAS TRANSFILLK091843COMFORT TWIN NASAL MASKK091066COMFORT TWIN NASAL MASK

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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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