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FDA 510(k)

ACCUSONIC ADVANTAGE

K-Number: K124010 · 2013-08-23

ApplicantMetron Medical Australia, Pty, Ltd.
Decision Date2013-08-23
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCUSONIC ADVANTAGE is the device name listed in this FDA 510(k) record. The listed applicant is Metron Medical Australia, Pty, Ltd.. It received FDA 510(k) clearance on 2013-08-23 under 510(k) number K124010. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSONIC ADVANTAGE?

ACCUSONIC ADVANTAGE is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Metron Medical Australia, Pty, Ltd.. The 510(k) number is K124010.

When did ACCUSONIC ADVANTAGE receive FDA 510(k) clearance?

ACCUSONIC ADVANTAGE received FDA 510(k) clearance on 2013-08-23, under 510(k) number K124010.

Who is the listed applicant for ACCUSONIC ADVANTAGE?

The FDA 510(k) record lists Metron Medical Australia, Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSONIC ADVANTAGE?

The FDA product code for ACCUSONIC ADVANTAGE is IMI.

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Other records listing Metron Medical Australia, Pty, 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.

K132137MULTISTIMK120171ACCUSONIC ADVANTAGEK030880VECTORSONIC, MODEL VU-270K030648VECTORSURGE 5 MODEL 470K030878ACCOUSONIC, MODEL AS-270K030410ACCOUSONIC PLUS, MODEL AP-170

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Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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