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FDA 510(k)

ALICE PDX

K-Number: K090484 · 2009-06-26

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-06-26
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ALICE PDX 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 2009-06-26 under 510(k) number K090484. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALICE PDX?

ALICE PDX is a medical device that received FDA 510(k) clearance on 2009-06-26. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K090484.

When did ALICE PDX receive FDA 510(k) clearance?

ALICE PDX received FDA 510(k) clearance on 2009-06-26, under 510(k) number K090484.

Who is the listed applicant for ALICE PDX?

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 ALICE PDX?

The FDA product code for ALICE PDX is MNR.

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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: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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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