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FDA 510(k)

Harioculture TL-16 Time-lapse Incubator

K-Number: K242684 · 2025-05-22

ApplicantHua Yue Medical Technology Co., Ltd.
Decision Date2025-05-22
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Harioculture TL-16 Time-lapse Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Hua Yue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K242684. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harioculture TL-16 Time-lapse Incubator?

Harioculture TL-16 Time-lapse Incubator is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K242684.

When did Harioculture TL-16 Time-lapse Incubator receive FDA 510(k) clearance?

Harioculture TL-16 Time-lapse Incubator received FDA 510(k) clearance on 2025-05-22, under 510(k) number K242684.

Who is the listed applicant for Harioculture TL-16 Time-lapse Incubator?

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

What is the FDA product code for Harioculture TL-16 Time-lapse Incubator?

The FDA product code for Harioculture TL-16 Time-lapse Incubator is MQG.

Other records listing Hua Yue Medical Technology Co., Ltd. as applicant

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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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