FDA 510(k)

Quicktome

K-Number: K203518 · 2021-03-09

ApplicantOmniscient Neurotechnology Pty Ltd (O8t)

Decision Date2021-03-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Quicktome is the device name listed in this FDA 510(k) record. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K203518. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quicktome?

Quicktome is a medical device that received FDA 510(k) clearance on 2021-03-09. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K203518.

When did Quicktome receive FDA 510(k) clearance?

Quicktome received FDA 510(k) clearance on 2021-03-09, under 510(k) number K203518.

Who is the listed applicant for Quicktome?

The FDA 510(k) record lists Omniscient Neurotechnology Pty Ltd (O8t) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quicktome?

The FDA product code for Quicktome is LLZ.

Other records listing Omniscient Neurotechnology Pty Ltd (O8t) 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.

K222359Quicktome Software Suite

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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.