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FDA 510(k)

INNOVISION-P5

K-Number: K250750 · 2025-07-18

ApplicantDk Medical Systems Co., Ltd.
Decision Date2025-07-18
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVISION-P5 is a medical device manufactured by Dk Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2025-07-18 under approval number K250750. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVISION-P5?

INNOVISION-P5 is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by Dk Medical Systems Co., Ltd.. The 510(k) number is K250750.

When was INNOVISION-P5 approved by the FDA?

INNOVISION-P5 received FDA 510(k) clearance on 2025-07-18, under approval number K250750.

What company makes INNOVISION-P5?

INNOVISION-P5 is manufactured by Dk Medical Systems Co., Ltd..

What is the FDA product code for INNOVISION-P5?

The FDA product code for INNOVISION-P5 is IZL.

Other Devices by Dk Medical Systems Co., Ltd.

K250790INNOVISION-DXII K253446AeroDR TX c02

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Official Source

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

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