Ultrasound Scanner System bk2300
K-Number: K180737 · 2018-08-01
ApplicantBk Medical Aps
Decision Date2018-08-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ultrasound Scanner System bk2300 is a medical device manufactured by Bk Medical Aps. It received FDA 510(k) clearance on 2018-08-01 under approval number K180737. 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 Ultrasound Scanner System bk2300?
Ultrasound Scanner System bk2300 is a medical device that received FDA 510(k) clearance on 2018-08-01. It is manufactured by Bk Medical Aps. The 510(k) number is K180737.
When was Ultrasound Scanner System bk2300 approved by the FDA?
Ultrasound Scanner System bk2300 received FDA 510(k) clearance on 2018-08-01, under approval number K180737.
What company makes Ultrasound Scanner System bk2300?
Ultrasound Scanner System bk2300 is manufactured by Bk Medical Aps.
What is the FDA product code for Ultrasound Scanner System bk2300?
The FDA product code for Ultrasound Scanner System bk2300 is IYN.
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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.