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FDA 510(k)

INFINITT DPS

K-Number: K243449 · 2025-12-09

ApplicantInfinitt Healthcare Co., Ltd.
Decision Date2025-12-09
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

INFINITT DPS is a medical device manufactured by Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under approval number K243449. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITT DPS?

INFINITT DPS is a medical device that received FDA 510(k) clearance on 2025-12-09. It is manufactured by Infinitt Healthcare Co., Ltd.. The 510(k) number is K243449.

When was INFINITT DPS approved by the FDA?

INFINITT DPS received FDA 510(k) clearance on 2025-12-09, under approval number K243449.

What company makes INFINITT DPS?

INFINITT DPS is manufactured by Infinitt Healthcare Co., Ltd..

What is the FDA product code for INFINITT DPS?

The FDA product code for INFINITT DPS is QKQ.

Other Devices by Infinitt Healthcare Co., Ltd.

K172803Infinitt PACS 7.0 K193369Xelis Dental 2.0 K193498Infinitt RT PACS

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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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