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FDA 510(k)

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

K-Number: K090804 · 2009-11-05

ApplicantInnomed Technologies, Inc./Respcare, Inc.
Decision Date2009-11-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Innomed Technologies, Inc./Respcare, Inc.. It received FDA 510(k) clearance on 2009-11-05 under 510(k) number K090804. 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 NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD?

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Innomed Technologies, Inc./Respcare, Inc.. The 510(k) number is K090804.

When did NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD receive FDA 510(k) clearance?

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD received FDA 510(k) clearance on 2009-11-05, under 510(k) number K090804.

Who is the listed applicant for NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD?

The FDA 510(k) record lists Innomed Technologies, Inc./Respcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD?

The FDA product code for NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD is BZD.

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Other records listing Innomed Technologies, Inc./Respcare, Inc. 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.

K062019RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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