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FDA 510(k)

NASAL AIRE

K-Number: K990659 · 1999-11-26

ApplicantBreathing Technologies Corp.
Decision Date1999-11-26
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASAL AIRE is the device name listed in this FDA 510(k) record. The listed applicant is Breathing Technologies Corp.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K990659. 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?

NASAL AIRE is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Breathing Technologies Corp.. The 510(k) number is K990659.

When did NASAL AIRE receive FDA 510(k) clearance?

NASAL AIRE received FDA 510(k) clearance on 1999-11-26, under 510(k) number K990659.

Who is the listed applicant for NASAL AIRE?

The FDA 510(k) record lists Breathing Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL AIRE?

The FDA product code for NASAL AIRE is BZD.

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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

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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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