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FDA 510(k)

ACHILLES

K-Number: K123238 · 2013-02-25

ApplicantGe Medical Systems China Co., Ltd.
Decision Date2013-02-25
Product CodeMUA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACHILLES is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems China Co., Ltd.. It received FDA 510(k) clearance on 2013-02-25 under 510(k) number K123238. The device is classified under product code MUA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACHILLES?

ACHILLES is a medical device that received FDA 510(k) clearance on 2013-02-25. The listed applicant is Ge Medical Systems China Co., Ltd.. The 510(k) number is K123238.

When did ACHILLES receive FDA 510(k) clearance?

ACHILLES received FDA 510(k) clearance on 2013-02-25, under 510(k) number K123238.

Who is the listed applicant for ACHILLES?

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

What is the FDA product code for ACHILLES?

The FDA product code for ACHILLES is MUA.

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Other records listing Ge Medical Systems China 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.

K171580Monitor B125, Monitor B105K130584MONITOR B40K122253PROCARE MONITOR B20K120598PROCARE MONITOR B40K103633ACHILLESK102256GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND

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Related Devices (Code: MUA)

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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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