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510(k) K242684

Harioculture TL-16 Time-lapse Incubator by Hua Yue Medical Technology Co., Ltd. — Product Code MQG

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

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