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510(k) K252669

Fetal Doppler U8-25, U9-25 by Zhongshan Xiaolan Town Senlan Electronic Factory — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2026
Date Received
August 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

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