FDA 510(k)

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

K-Number: K100919 · 2011-12-16

Decision Date2011-12-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical Aps. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K100919. 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 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202?

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is B-K Medical Aps. The 510(k) number is K100919.

When did PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 receive FDA 510(k) clearance?

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 received FDA 510(k) clearance on 2011-12-16, under 510(k) number K100919.

Who is the listed applicant for PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202?

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

What is the FDA product code for PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202?

The FDA product code for PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 is IYN.

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Other records listing B-K Medical Aps as applicant

K123254ULTRASOUND SCANNER FLEX FOCUS K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 K070077ULTRASOUND SCANNER PROFOCUS, MODEL 2202

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.