FDA 510(k)

bk2300

K-Number: K161960 · 2016-10-17

Decision Date2016-10-17

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

bk2300 is the device name listed in this FDA 510(k) record. The listed applicant is Bk Medical Aps. It received FDA 510(k) clearance on 2016-10-17 under 510(k) 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. The listed applicant is Bk Medical Aps. The 510(k) number is K161960.

When did bk2300 receive FDA 510(k) clearance?

bk2300 received FDA 510(k) clearance on 2016-10-17, under 510(k) number K161960.

Who is the listed applicant for bk2300?

The FDA 510(k) record lists Bk Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for bk2300?

The FDA product code for bk2300 is IYN.

Other records listing Bk Medical Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231764Ultrasound System 1300 K223830Ultrasound System 2300 K222441Ultrasound System 2300 K180737Ultrasound Scanner System bk2300 K173569Ultrasound System 1300

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.