FDA 510(k)

Dolphin Medical Imaging USB Ultrasound System

Número K: K192573 · 2019-11-19

Data da decisão2019-11-19

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dolphin Medical Imaging USB Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Dolphin Medical Imaging, LLC. It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K192573. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dolphin Medical Imaging USB Ultrasound System?

Dolphin Medical Imaging USB Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Dolphin Medical Imaging, LLC. The 510(k) number is K192573.

When did Dolphin Medical Imaging USB Ultrasound System receive FDA 510(k) clearance?

Dolphin Medical Imaging USB Ultrasound System received FDA 510(k) clearance on 2019-11-19, under 510(k) number K192573.

Who is the listed applicant for Dolphin Medical Imaging USB Ultrasound System?

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

What is the FDA product code for Dolphin Medical Imaging USB Ultrasound System?

The FDA product code for Dolphin Medical Imaging USB Ultrasound System is IYO.

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