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FDA 510(k)

Quantib Brain 1.2

K-Number: K163013 · 2017-01-06

ApplicantQuantib B.V.
Decision Date2017-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Quantib Brain 1.2 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 2017-01-06 under 510(k) number K163013. 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 Brain 1.2?

Quantib Brain 1.2 is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Quantib B.V.. The 510(k) number is K163013.

When did Quantib Brain 1.2 receive FDA 510(k) clearance?

Quantib Brain 1.2 received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163013.

Who is the listed applicant for Quantib Brain 1.2?

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 Brain 1.2?

The FDA product code for Quantib Brain 1.2 is LLZ.

Other records listing Quantib B.V. as applicant

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Related Devices (Code: LLZ)

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.

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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.

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