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FDA 510(k)

SOMNODENT G2

K-Number: K121340 · 2012-05-30

ApplicantSomnomed, Inc.
Decision Date2012-05-30
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOMNODENT G2 is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K121340. 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 SOMNODENT G2?

SOMNODENT G2 is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Somnomed, Inc.. The 510(k) number is K121340.

When did SOMNODENT G2 receive FDA 510(k) clearance?

SOMNODENT G2 received FDA 510(k) clearance on 2012-05-30, under 510(k) number K121340.

Who is the listed applicant for SOMNODENT G2?

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

What is the FDA product code for SOMNODENT G2?

The FDA product code for SOMNODENT G2 is LRK.

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Other records listing Somnomed, 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.

K261366VirtusK233497Rest Assure SystemK183443SomnoDent AvantK162306SomnoDent ALPHAK130558SOMNODENT HERBST; CLASSIC, FLEXK102909SOMNOBRUX SPLINTS

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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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