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FDA 510(k)

Oral Device OA, Oral Device S

K-Number: K181396 · 2018-11-16

ApplicantPassion For Life Healthcare (Uk) Limited
Decision Date2018-11-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Oral Device OA, Oral Device S is the device name listed in this FDA 510(k) record. The listed applicant is Passion For Life Healthcare (Uk) Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181396. 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 Oral Device OA, Oral Device S?

Oral Device OA, Oral Device S is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Passion For Life Healthcare (Uk) Limited. The 510(k) number is K181396.

When did Oral Device OA, Oral Device S receive FDA 510(k) clearance?

Oral Device OA, Oral Device S received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181396.

Who is the listed applicant for Oral Device OA, Oral Device S?

The FDA 510(k) record lists Passion For Life Healthcare (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oral Device OA, Oral Device S?

The FDA product code for Oral Device OA, Oral Device S 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.

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