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FDA 510(k)

NASALFLAIR

K-Number: K951944 · 1997-03-28

ApplicantAirways Ltd., Inc.
Decision Date1997-03-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASALFLAIR is the device name listed in this FDA 510(k) record. The listed applicant is Airways Ltd., Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K951944. 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 NASALFLAIR?

NASALFLAIR is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Airways Ltd., Inc.. The 510(k) number is K951944.

When did NASALFLAIR receive FDA 510(k) clearance?

NASALFLAIR received FDA 510(k) clearance on 1997-03-28, under 510(k) number K951944.

Who is the listed applicant for NASALFLAIR?

The FDA 510(k) record lists Airways Ltd., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASALFLAIR?

The FDA product code for NASALFLAIR is BZD.

Related Clinical Trials

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.

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Other records listing Airways Ltd., 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.

K032922CLARISSA INFANT NCPAP CANNULA

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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