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FDA 510(k)

INNOVISION-EXII

K-Number: K242119 · 2025-01-03

ApplicantDk Medical System
Decision Date2025-01-03
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVISION-EXII is a medical device manufactured by Dk Medical System. It received FDA 510(k) clearance on 2025-01-03 under approval number K242119. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVISION-EXII?

INNOVISION-EXII is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Dk Medical System. The 510(k) number is K242119.

When was INNOVISION-EXII approved by the FDA?

INNOVISION-EXII received FDA 510(k) clearance on 2025-01-03, under approval number K242119.

What company makes INNOVISION-EXII?

INNOVISION-EXII is manufactured by Dk Medical System.

What is the FDA product code for INNOVISION-EXII?

The FDA product code for INNOVISION-EXII is KPR.

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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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