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FDA 510(k)

ANTI-SNORING DEVICE OR ASD

K-Number: K011723 · 2002-12-18

ApplicantPi Medical
Decision Date2002-12-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTI-SNORING DEVICE OR ASD is the device name listed in this FDA 510(k) record. The listed applicant is Pi Medical. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K011723. 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 ANTI-SNORING DEVICE OR ASD?

ANTI-SNORING DEVICE OR ASD is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Pi Medical. The 510(k) number is K011723.

When did ANTI-SNORING DEVICE OR ASD receive FDA 510(k) clearance?

ANTI-SNORING DEVICE OR ASD received FDA 510(k) clearance on 2002-12-18, under 510(k) number K011723.

Who is the listed applicant for ANTI-SNORING DEVICE OR ASD?

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

What is the FDA product code for ANTI-SNORING DEVICE OR ASD?

The FDA product code for ANTI-SNORING DEVICE OR ASD 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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