Quicktome
K-Number: K203518 · 2021-03-09
Decision Date2021-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quicktome is a medical device manufactured by Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2021-03-09 under approval 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. It is manufactured by Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K203518.
When was Quicktome approved by the FDA?
Quicktome received FDA 510(k) clearance on 2021-03-09, under approval number K203518.
What company makes Quicktome?
Quicktome is manufactured by Omniscient Neurotechnology Pty Ltd (O8t).
What is the FDA product code for Quicktome?
The FDA product code for Quicktome is LLZ.
Other Devices by Omniscient Neurotechnology Pty Ltd (O8t)
Related Devices (Code: LLZ)
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.