Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Snorer's Friend

K-Number: K171529 · 2018-01-02

ApplicantScope Healthcare Technologies Pty, Ltd.
Decision Date2018-01-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Snorer's Friend is the device name listed in this FDA 510(k) record. The listed applicant is Scope Healthcare Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-02 under 510(k) number K171529. 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 Snorer's Friend?

Snorer's Friend is a medical device that received FDA 510(k) clearance on 2018-01-02. The listed applicant is Scope Healthcare Technologies Pty, Ltd.. The 510(k) number is K171529.

When did Snorer's Friend receive FDA 510(k) clearance?

Snorer's Friend received FDA 510(k) clearance on 2018-01-02, under 510(k) number K171529.

Who is the listed applicant for Snorer's Friend?

The FDA 510(k) record lists Scope Healthcare Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snorer's Friend?

The FDA product code for Snorer's Friend is LRK.

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.

↑