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FDA 510(k)

REMSTAR AUTO A-FLEX

K-Number: K091319 · 2009-08-03

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-08-03
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REMSTAR AUTO A-FLEX 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 2009-08-03 under 510(k) number K091319. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMSTAR AUTO A-FLEX?

REMSTAR AUTO A-FLEX is a medical device that received FDA 510(k) clearance on 2009-08-03. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K091319.

When did REMSTAR AUTO A-FLEX receive FDA 510(k) clearance?

REMSTAR AUTO A-FLEX received FDA 510(k) clearance on 2009-08-03, under 510(k) number K091319.

Who is the listed applicant for REMSTAR AUTO A-FLEX?

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 REMSTAR AUTO A-FLEX?

The FDA product code for REMSTAR AUTO A-FLEX is BZD.

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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: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC 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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