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FDA 510(k)

ANTI-SNORING / SLEEP APNEA DEVICE

K-Number: K061688 · 2006-09-08

ApplicantTomed Dr. Toussaint GmbH
Decision Date2006-09-08
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTI-SNORING / SLEEP APNEA DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tomed Dr. Toussaint GmbH. It received FDA 510(k) clearance on 2006-09-08 under 510(k) number K061688. 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 / SLEEP APNEA DEVICE?

ANTI-SNORING / SLEEP APNEA DEVICE is a medical device that received FDA 510(k) clearance on 2006-09-08. The listed applicant is Tomed Dr. Toussaint GmbH. The 510(k) number is K061688.

When did ANTI-SNORING / SLEEP APNEA DEVICE receive FDA 510(k) clearance?

ANTI-SNORING / SLEEP APNEA DEVICE received FDA 510(k) clearance on 2006-09-08, under 510(k) number K061688.

Who is the listed applicant for ANTI-SNORING / SLEEP APNEA DEVICE?

The FDA 510(k) record lists Tomed Dr. Toussaint GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-SNORING / SLEEP APNEA DEVICE?

The FDA product code for ANTI-SNORING / SLEEP APNEA DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tomed Dr. Toussaint GmbH 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.

K121761SOMNOGUARD SP SOFT

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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