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FDA 510(k)

BREATHE RIGHT

K-Number: K921220 · 1993-10-07

ApplicantCns, Inc.
Decision Date1993-10-07
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BREATHE RIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Cns, Inc.. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K921220. 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 BREATHE RIGHT?

BREATHE RIGHT is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Cns, Inc.. The 510(k) number is K921220.

When did BREATHE RIGHT receive FDA 510(k) clearance?

BREATHE RIGHT received FDA 510(k) clearance on 1993-10-07, under 510(k) number K921220.

Who is the listed applicant for BREATHE RIGHT?

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

What is the FDA product code for BREATHE RIGHT?

The FDA product code for BREATHE RIGHT is LWF.

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 Cns, 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.

K955711BREATHE RIGHT NASAL STRIPK954914BREATHE RIGHT NASAL STRIPK953772BREATHE RIGHT NASAL STRIPK950273SLEEP TEST(TM)K912436AM-PAKK904432SLEEP I/T-5 AND SLEEP I/T-8

View all 14 devices →

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.K962400AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, 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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