FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

K-Nummer: K192303 · 2019-10-01

Entscheidungsdatum2019-10-01

ProduktcodeIYN

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, Inc.. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192303. The device is classified under product code IYN. 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 2019-10-01. The listed applicant is Exact Imaging, Inc.. The 510(k) number is K192303.

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 2019-10-01, under 510(k) number K192303.

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

The FDA 510(k) record lists Exact Imaging, Inc. 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 IYN.

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Weitere Einträge mit Exact Imaging, Inc. als Antragsteller

K190995ExactVu High Resolution Micro-Ultrasound System K180636ExactVu High Resolution Micro-Ultrasound System

Verwandte Geräte (Code: IYN)

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