bk2300
K-Number: K161960 · 2016-10-17
ApplicantBk Medical Aps
Decision Date2016-10-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
bk2300 is a medical device manufactured by Bk Medical Aps. It received FDA 510(k) clearance on 2016-10-17 under approval number K161960. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the bk2300?
bk2300 is a medical device that received FDA 510(k) clearance on 2016-10-17. It is manufactured by Bk Medical Aps. The 510(k) number is K161960.
When was bk2300 approved by the FDA?
bk2300 received FDA 510(k) clearance on 2016-10-17, under approval number K161960.
What company makes bk2300?
bk2300 is manufactured by Bk Medical Aps.
What is the FDA product code for bk2300?
The FDA product code for bk2300 is IYN.
Other Devices by Bk Medical Aps
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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.