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FDA 510(k)

EMS-200

K-Number: K153285 · 2016-08-12

ApplicantMeta Systems Co., Ltd.
Decision Date2016-08-12
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMS-200 is a medical device manufactured by Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-08-12 under approval number K153285. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS-200?

EMS-200 is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Meta Systems Co., Ltd.. The 510(k) number is K153285.

When was EMS-200 approved by the FDA?

EMS-200 received FDA 510(k) clearance on 2016-08-12, under approval number K153285.

What company makes EMS-200?

EMS-200 is manufactured by Meta Systems Co., Ltd..

What is the FDA product code for EMS-200?

The FDA product code for EMS-200 is EKX.

Other Devices by Meta Systems Co., Ltd.

K210789EQ-PEX K210475EQ-M K253461Demi Pro

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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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