FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

K-Nummer: K162972 · 2016-12-02

Entscheidungsdatum2016-12-02

ProduktcodeIYO

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

ExactVu High Resolution Micro-Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Exact Imaging. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K162972. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the ExactVu High Resolution Micro-Ultrasound System?

ExactVu High Resolution Micro-Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Exact Imaging. The 510(k) number is K162972.

When did ExactVu High Resolution Micro-Ultrasound System receive FDA 510(k) clearance?

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K162972.

Who is the listed applicant for ExactVu High Resolution Micro-Ultrasound System?

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

What is the FDA product code for ExactVu High Resolution Micro-Ultrasound System?

The FDA product code for ExactVu High Resolution Micro-Ultrasound System is IYO.

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Verwandte Geräte (Code: IYO)

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Offizielle Quelle

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