FDA 510(k)

INFINITT DPS

K-Number: K243449 · 2025-12-09

Decision Date2025-12-09

Product CodeQKQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

INFINITT DPS is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) 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. The listed applicant is Infinitt Healthcare Co., Ltd.. The 510(k) number is K243449.

When did INFINITT DPS receive FDA 510(k) clearance?

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

Who is the listed applicant for INFINITT DPS?

The FDA 510(k) record lists Infinitt Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITT DPS?

The FDA product code for INFINITT DPS is QKQ.

Other records listing Infinitt Healthcare Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193369Xelis Dental 2.0 K193498Infinitt RT PACS K172803Infinitt PACS 7.0

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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.