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FDA 510(k)

ApneaRX Pro

K-Number: K223901 · 2023-09-01

ApplicantApnea Sciences Coporation
Decision Date2023-09-01
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ApneaRX Pro is the device name listed in this FDA 510(k) record. The listed applicant is Apnea Sciences Coporation. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K223901. 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 ApneaRX Pro?

ApneaRX Pro is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Apnea Sciences Coporation. The 510(k) number is K223901.

When did ApneaRX Pro receive FDA 510(k) clearance?

ApneaRX Pro received FDA 510(k) clearance on 2023-09-01, under 510(k) number K223901.

Who is the listed applicant for ApneaRX Pro?

The FDA 510(k) record lists Apnea Sciences Coporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ApneaRX Pro?

The FDA product code for ApneaRX Pro 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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