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FDA 510(k)

DR. B'S MOUTHPIECE, MODEL 32129-10002

K-Number: K991948 · 1999-09-02

ApplicantSnore - Ezzer
Decision Date1999-09-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DR. B'S MOUTHPIECE, MODEL 32129-10002 is the device name listed in this FDA 510(k) record. The listed applicant is Snore - Ezzer. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K991948. 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 DR. B'S MOUTHPIECE, MODEL 32129-10002?

DR. B'S MOUTHPIECE, MODEL 32129-10002 is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is Snore - Ezzer. The 510(k) number is K991948.

When did DR. B'S MOUTHPIECE, MODEL 32129-10002 receive FDA 510(k) clearance?

DR. B'S MOUTHPIECE, MODEL 32129-10002 received FDA 510(k) clearance on 1999-09-02, under 510(k) number K991948.

Who is the listed applicant for DR. B'S MOUTHPIECE, MODEL 32129-10002?

The FDA 510(k) record lists Snore - Ezzer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR. B'S MOUTHPIECE, MODEL 32129-10002?

The FDA product code for DR. B'S MOUTHPIECE, MODEL 32129-10002 is LRK.

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 Snore - Ezzer 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.

K974531SNORE-EZZER

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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