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FDA 510(k)

IntraSight Mobile

K-Number: K203719 · 2021-01-19

ApplicantVolcano Corporation
Decision Date2021-01-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IntraSight Mobile is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2021-01-19 under approval number K203719. 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 IntraSight Mobile?

IntraSight Mobile is a medical device that received FDA 510(k) clearance on 2021-01-19. It is manufactured by Volcano Corporation. The 510(k) number is K203719.

When was IntraSight Mobile approved by the FDA?

IntraSight Mobile received FDA 510(k) clearance on 2021-01-19, under approval number K203719.

What company makes IntraSight Mobile?

IntraSight Mobile is manufactured by Volcano Corporation.

What is the FDA product code for IntraSight Mobile?

The FDA product code for IntraSight Mobile is IYO.

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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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