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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 a medical device manufactured by Hua Yue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under approval 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. It is manufactured by Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K242684.

When was Harioculture TL-16 Time-lapse Incubator approved by the FDA?

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

What company makes Harioculture TL-16 Time-lapse Incubator?

Harioculture TL-16 Time-lapse Incubator is manufactured by Hua Yue Medical Technology Co., Ltd..

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.

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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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