FDA 510(k)

trophon Wireless Ultrasound Probe Holder

K-Number: K241536 · 2024-09-27

Decision Date2024-09-27

Product CodeOUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

trophon Wireless Ultrasound Probe Holder is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics Limited. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241536. 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 Wireless Ultrasound Probe Holder?

trophon Wireless Ultrasound Probe Holder is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Nanosonics Limited. The 510(k) number is K241536.

When did trophon Wireless Ultrasound Probe Holder receive FDA 510(k) clearance?

trophon Wireless Ultrasound Probe Holder received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241536.

Who is the listed applicant for trophon Wireless Ultrasound Probe Holder?

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 Wireless Ultrasound Probe Holder?

The FDA product code for trophon Wireless Ultrasound Probe Holder is OUJ.

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 System K250434trophon2 K173865trophon2

Related Devices (Code: OUJ)

K250434trophon2Nanosonics K173865trophon2Nanosonics 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.