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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 the device name listed in this FDA 510(k) record. The listed applicant is Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-08-12 under 510(k) 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. The listed applicant is Meta Systems Co., Ltd.. The 510(k) number is K153285.

When did EMS-200 receive FDA 510(k) clearance?

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

Who is the listed applicant for EMS-200?

The FDA 510(k) record lists Meta Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS-200?

The FDA product code for EMS-200 is EKX.

Other records listing Meta Systems Co., Ltd. as applicant

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.

K253461Demi ProK210475EQ-MK210789EQ-PEX

Related Devices (Code: EKX)

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.

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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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