Harioculture TL-16 Time-lapse Incubator
FDA 510(k) K242684 · Hua Yue Medical Technology Co., Ltd.
510(k) numberK242684
Submission
- Device name
- Harioculture TL-16 Time-lapse Incubator
- Applicant
- Hua Yue Medical Technology Co., Ltd.
Guangzhou, CN - Received
- September 6, 2024
- Decision date
- May 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQG – Accessory, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
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| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
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Questions and answers
When was Harioculture TL-16 Time-lapse Incubator cleared by the FDA?
Harioculture TL-16 Time-lapse Incubator (K242684) received a 510(k) decision of Substantially Equivalent on May 22, 2025, 258 days after the submission was received.
What is the product code of K242684?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.