ADAS 3D
K-Number: K191125 · 2020-01-15
ApplicantGalgo Medical S.L
Decision Date2020-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ADAS 3D is a medical device manufactured by Galgo Medical S.L. It received FDA 510(k) clearance on 2020-01-15 under approval number K191125. 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 ADAS 3D?
ADAS 3D is a medical device that received FDA 510(k) clearance on 2020-01-15. It is manufactured by Galgo Medical S.L. The 510(k) number is K191125.
When was ADAS 3D approved by the FDA?
ADAS 3D received FDA 510(k) clearance on 2020-01-15, under approval number K191125.
What company makes ADAS 3D?
ADAS 3D is manufactured by Galgo Medical S.L.
What is the FDA product code for ADAS 3D?
The FDA product code for ADAS 3D is LLZ.
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.