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FDA 510(k)

SoftVue

K-Number: K172256 · 2018-03-02

ApplicantDelphinus Medical Technologies
Decision Date2018-03-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SoftVue is a medical device manufactured by Delphinus Medical Technologies. It received FDA 510(k) clearance on 2018-03-02 under approval number K172256. 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 SoftVue?

SoftVue is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Delphinus Medical Technologies. The 510(k) number is K172256.

When was SoftVue approved by the FDA?

SoftVue received FDA 510(k) clearance on 2018-03-02, under approval number K172256.

What company makes SoftVue?

SoftVue is manufactured by Delphinus Medical Technologies.

What is the FDA product code for SoftVue?

The FDA product code for SoftVue is IYO.

Other Devices by Delphinus Medical Technologies

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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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