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FDA 510(k)

COMFORTGEL NASAL MASK

K-Number: K092835 · 2010-02-12

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2010-02-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMFORTGEL NASAL MASK 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 2010-02-12 under 510(k) number K092835. 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 COMFORTGEL NASAL MASK?

COMFORTGEL NASAL MASK is a medical device that received FDA 510(k) clearance on 2010-02-12. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K092835.

When did COMFORTGEL NASAL MASK receive FDA 510(k) clearance?

COMFORTGEL NASAL MASK received FDA 510(k) clearance on 2010-02-12, under 510(k) number K092835.

Who is the listed applicant for COMFORTGEL NASAL MASK?

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 COMFORTGEL NASAL MASK?

The FDA product code for COMFORTGEL NASAL MASK 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.

K092648RESPIRONICS PERFORMAX SE TOTAL FACE MASKK090539BIPAP AUTOSV ADVANCEDK091191GAS TRANSFILLK091843COMFORT TWIN NASAL MASKK091066COMFORT TWIN NASAL MASKK091319REMSTAR AUTO A-FLEX

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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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