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FDA 510(k)

MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

K-Number: K011955 · 2001-07-16

ApplicantMetron Medical Australia, Pty, Ltd.
Decision Date2001-07-16
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 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 2001-07-16 under 510(k) number K011955. 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 MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100?

MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 is a medical device that received FDA 510(k) clearance on 2001-07-16. The listed applicant is Metron Medical Australia, Pty, Ltd.. The 510(k) number is K011955.

When did MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 receive FDA 510(k) clearance?

MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 received FDA 510(k) clearance on 2001-07-16, under 510(k) number K011955.

Who is the listed applicant for MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100?

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 MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100?

The FDA product code for MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 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.

K132137MULTISTIMK124010ACCUSONIC ADVANTAGEK120171ACCUSONIC ADVANTAGEK030880VECTORSONIC, MODEL VU-270K030648VECTORSURGE 5 MODEL 470K030878ACCOUSONIC, MODEL AS-270

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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.

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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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