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FDA 510(k)

SILENT SLEEP

K-Number: K082849 · 2009-07-16

ApplicantCraniofacial Pain Center of Idaho
Decision Date2009-07-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILENT SLEEP is the device name listed in this FDA 510(k) record. The listed applicant is Craniofacial Pain Center of Idaho. It received FDA 510(k) clearance on 2009-07-16 under 510(k) number K082849. 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 SILENT SLEEP?

SILENT SLEEP is a medical device that received FDA 510(k) clearance on 2009-07-16. The listed applicant is Craniofacial Pain Center of Idaho. The 510(k) number is K082849.

When did SILENT SLEEP receive FDA 510(k) clearance?

SILENT SLEEP received FDA 510(k) clearance on 2009-07-16, under 510(k) number K082849.

Who is the listed applicant for SILENT SLEEP?

The FDA 510(k) record lists Craniofacial Pain Center of Idaho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILENT SLEEP?

The FDA product code for SILENT SLEEP is LRK.

Related Clinical Trials

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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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