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FDA 510(k)

Vu-Path Ultrasound System

K-Number: K203657 · 2021-06-25

ApplicantCrystalline Medical
Decision Date2021-06-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vu-Path Ultrasound System is a medical device manufactured by Crystalline Medical. It received FDA 510(k) clearance on 2021-06-25 under approval number K203657. 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 Vu-Path Ultrasound System?

Vu-Path Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-06-25. It is manufactured by Crystalline Medical. The 510(k) number is K203657.

When was Vu-Path Ultrasound System approved by the FDA?

Vu-Path Ultrasound System received FDA 510(k) clearance on 2021-06-25, under approval number K203657.

What company makes Vu-Path Ultrasound System?

Vu-Path Ultrasound System is manufactured by Crystalline Medical.

What is the FDA product code for Vu-Path Ultrasound System?

The FDA product code for Vu-Path Ultrasound System is IYN.

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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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