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FDA 510(k)

EMA 3D

K-Number: K232735 · 2024-05-03

ApplicantEma Sleep Incorporated
Decision Date2024-05-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ema Sleep Incorporated. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232735. 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 EMA 3D?

EMA 3D is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Ema Sleep Incorporated. The 510(k) number is K232735.

When did EMA 3D receive FDA 510(k) clearance?

EMA 3D received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232735.

Who is the listed applicant for EMA 3D?

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

What is the FDA product code for EMA 3D?

The FDA product code for EMA 3D 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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