Home / 510(k) Clearances / K182526

510(k) K182526

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) by Vcomin Technology Limited — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2019
Date Received
September 11, 2018
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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