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FDA 510(k)

KOALA

K-Number: K192109 · 2019-11-05

ApplicantIb Lab GmbH
Decision Date2019-11-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KOALA is a medical device manufactured by Ib Lab GmbH. It received FDA 510(k) clearance on 2019-11-05 under approval 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. It is manufactured by Ib Lab GmbH. The 510(k) number is K192109.

When was KOALA approved by the FDA?

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

What company makes KOALA?

KOALA is manufactured by Ib Lab GmbH.

What is the FDA product code for KOALA?

The FDA product code for KOALA is LLZ.

Other Devices by Ib Lab GmbH

K223646IB Lab LAMA

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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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