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FDA 510(k)

Dolphin Medical Imaging USB Ultrasound System

K-Number: K192573 · 2019-11-19

ApplicantDolphin Medical Imaging, LLC
Decision Date2019-11-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Dolphin Medical Imaging, LLC. The 510(k) number is K192573.

When was Dolphin Medical Imaging USB Ultrasound System approved by the FDA?

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

What company makes Dolphin Medical Imaging USB Ultrasound System?

Dolphin Medical Imaging USB Ultrasound System is manufactured by Dolphin Medical Imaging, LLC.

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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Related PubMed Literature

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Official Source

View on FDA Database →

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

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