510(k) K242684
K242684 is an FDA 510(k) premarket notification submitted by Hua Yue Medical Technology Co., Ltd. for the device "Harioculture TL-16 Time-lapse Incubator". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Hua Yue Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2025
- Date Received
- September 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type