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 a medical device manufactured by Ema Sleep Incorporated. It received FDA 510(k) clearance on 2024-05-03 under approval 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. It is manufactured by Ema Sleep Incorporated. The 510(k) number is K232735.
When was EMA 3D approved by the FDA?
EMA 3D received FDA 510(k) clearance on 2024-05-03, under approval number K232735.
What company makes EMA 3D?
EMA 3D is manufactured by Ema Sleep Incorporated.
What is the FDA product code for EMA 3D?
The FDA product code for EMA 3D is LRK.
Related Devices (Code: LRK)
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.