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FDA 510(k)

HEALTHY SLEEP APPLIANCE

K-Number: K123410 · 2013-04-05

ApplicantHealthy Sleep Dental Laboratory
Decision Date2013-04-05
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEALTHY SLEEP APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Healthy Sleep Dental Laboratory. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K123410. 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 HEALTHY SLEEP APPLIANCE?

HEALTHY SLEEP APPLIANCE is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Healthy Sleep Dental Laboratory. The 510(k) number is K123410.

When did HEALTHY SLEEP APPLIANCE receive FDA 510(k) clearance?

HEALTHY SLEEP APPLIANCE received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123410.

Who is the listed applicant for HEALTHY SLEEP APPLIANCE?

The FDA 510(k) record lists Healthy Sleep Dental Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTHY SLEEP APPLIANCE?

The FDA product code for HEALTHY SLEEP APPLIANCE 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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