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FDA 510(k)

SNOR-X MOUTH GUARD

K-Number: K954324 · 1995-10-17

ApplicantSnorex, Inc.
Decision Date1995-10-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SNOR-X MOUTH GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Snorex, Inc.. It received FDA 510(k) clearance on 1995-10-17 under 510(k) number K954324. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNOR-X MOUTH GUARD?

SNOR-X MOUTH GUARD is a medical device that received FDA 510(k) clearance on 1995-10-17. The listed applicant is Snorex, Inc.. The 510(k) number is K954324.

When did SNOR-X MOUTH GUARD receive FDA 510(k) clearance?

SNOR-X MOUTH GUARD received FDA 510(k) clearance on 1995-10-17, under 510(k) number K954324.

Who is the listed applicant for SNOR-X MOUTH GUARD?

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

What is the FDA product code for SNOR-X MOUTH GUARD?

The FDA product code for SNOR-X MOUTH GUARD is LRK.

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Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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