Quantib Prostate
K-Number: K221106 · 2022-05-13
ApplicantQuantib B.V.
Decision Date2022-05-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quantib Prostate is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2022-05-13 under approval number K221106. 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 Quantib Prostate?
Quantib Prostate is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Quantib B.V.. The 510(k) number is K221106.
When was Quantib Prostate approved by the FDA?
Quantib Prostate received FDA 510(k) clearance on 2022-05-13, under approval number K221106.
What company makes Quantib Prostate?
Quantib Prostate is manufactured by Quantib B.V..
What is the FDA product code for Quantib Prostate?
The FDA product code for Quantib Prostate is LLZ.
Related Clinical Trials
Other Devices by Quantib B.V.
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.