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FDA 510(k)

TROPHON

K-Number: K103059 · 2011-02-24

ApplicantNanosonics Limited
Decision Date2011-02-24
Product CodeOUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TROPHON is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics Limited. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K103059. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROPHON?

TROPHON is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Nanosonics Limited. The 510(k) number is K103059.

When did TROPHON receive FDA 510(k) clearance?

TROPHON received FDA 510(k) clearance on 2011-02-24, under 510(k) number K103059.

Who is the listed applicant for TROPHON?

The FDA 510(k) record lists Nanosonics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROPHON?

The FDA product code for TROPHON is OUJ.

Related Clinical Trials

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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Other records listing Nanosonics Limited 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.

K253267CORIS SystemK241536trophon Wireless Ultrasound Probe HolderK173865trophon2K103126TROPHON CHEMICAL INDICATOR

Related Devices (Code: OUJ)

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.

K250434trophon2NanosonicsK241536trophon Wireless Ultrasound Probe HolderNanosonics LimitedK173865trophon2Nanosonics Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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