Kleiner KG2 System
K-Number: K211474 · 2021-09-14
ApplicantBAAT Medical Products B.V.
Decision Date2021-09-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Kleiner KG2 System is a medical device manufactured by BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2021-09-14 under approval number K211474. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kleiner KG2 System?
Kleiner KG2 System is a medical device that received FDA 510(k) clearance on 2021-09-14. It is manufactured by BAAT Medical Products B.V.. The 510(k) number is K211474.
When was Kleiner KG2 System approved by the FDA?
Kleiner KG2 System received FDA 510(k) clearance on 2021-09-14, under approval number K211474.
What company makes Kleiner KG2 System?
Kleiner KG2 System is manufactured by BAAT Medical Products B.V..
What is the FDA product code for Kleiner KG2 System?
The FDA product code for Kleiner KG2 System is MAX.
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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.