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FDA 510(k)

Apollo Quattro (APQ-10M)

K-Number: K253542 · 2026-06-08

Decision Date2026-06-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Apollo Quattro (APQ-10M) is the device name listed in this FDA 510(k) record. The listed applicant is Weero Co., Ltd.. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K253542. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apollo Quattro (APQ-10M)?

Apollo Quattro (APQ-10M) is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is Weero Co., Ltd.. The 510(k) number is K253542.

When did Apollo Quattro (APQ-10M) receive FDA 510(k) clearance?

Apollo Quattro (APQ-10M) received FDA 510(k) clearance on 2026-06-08, under 510(k) number K253542.

Who is the listed applicant for Apollo Quattro (APQ-10M)?

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

What is the FDA product code for Apollo Quattro (APQ-10M)?

The FDA product code for Apollo Quattro (APQ-10M) is IPF.

Other records listing Weero 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.

Related Devices (Code: IPF)

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.

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.