FDA 510(k)

KOALA

K-Number: K192109 · 2019-11-05

Decision Date2019-11-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

KOALA is the device name listed in this FDA 510(k) record. The listed applicant is Ib Lab GmbH. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K192109. 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 KOALA?

KOALA is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Ib Lab GmbH. The 510(k) number is K192109.

When did KOALA receive FDA 510(k) clearance?

KOALA received FDA 510(k) clearance on 2019-11-05, under 510(k) number K192109.

Who is the listed applicant for KOALA?

The FDA 510(k) record lists Ib Lab GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOALA?

The FDA product code for KOALA is LLZ.

Other records listing Ib Lab GmbH 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.

K223646IB Lab LAMA

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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.