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FDA 510(k)

AIR MAX EXTERNAL NASAL DILATOR STRIP

K-Number: K962400 · 1996-09-09

ApplicantAmerican White Cross, Inc.
Decision Date1996-09-09
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AIR MAX EXTERNAL NASAL DILATOR STRIP is the device name listed in this FDA 510(k) record. The listed applicant is American White Cross, Inc.. It received FDA 510(k) clearance on 1996-09-09 under 510(k) number K962400. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR MAX EXTERNAL NASAL DILATOR STRIP?

AIR MAX EXTERNAL NASAL DILATOR STRIP is a medical device that received FDA 510(k) clearance on 1996-09-09. The listed applicant is American White Cross, Inc.. The 510(k) number is K962400.

When did AIR MAX EXTERNAL NASAL DILATOR STRIP receive FDA 510(k) clearance?

AIR MAX EXTERNAL NASAL DILATOR STRIP received FDA 510(k) clearance on 1996-09-09, under 510(k) number K962400.

Who is the listed applicant for AIR MAX EXTERNAL NASAL DILATOR STRIP?

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

What is the FDA product code for AIR MAX EXTERNAL NASAL DILATOR STRIP?

The FDA product code for AIR MAX EXTERNAL NASAL DILATOR STRIP is LWF.

Related Clinical Trials

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Other records listing American White Cross, 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.

K964614ULTRAFERA WOUND DRESSINGK894802AWC BUTTERFLY WOUND CLOSURESK854809WHITE CROSS STERILE PAD 4IN. X 4IN.K853558DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZK853334NON-ADHERA ADHESIVE PAD 3X4K852412NON-ADHERENT PAD

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Related Devices (Code: LWF)

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.

K181219OptiPillows EPAP MaskCpapnea Medical SupplyK120665INVENT SNORING DEVICEVentus Medical, Inc.K040491CHIN-UP STRIPDale Miller, Inc. - the Chin-Up CompanyK982929MAXAIR NASAL DILATOR SYSTEMHnl TechnologiesK963326BREATHE FITCambridge Assoc.K962698ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, Inc.

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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