FDA 510(k)

Quantib ND

K-Number: K213737 · 2022-01-14

Decision Date2022-01-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Quantib ND is the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213737. 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 ND?

Quantib ND is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Quantib B.V.. The 510(k) number is K213737.

When did Quantib ND receive FDA 510(k) clearance?

Quantib ND received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213737.

Who is the listed applicant for Quantib ND?

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

What is the FDA product code for Quantib ND?

The FDA product code for Quantib ND is LLZ.

Other records listing Quantib B.V. as applicant

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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.