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510(k) K211940

Fetal Doppler by Shenzhen Taikang Medical Equipment Co., Ltd. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
June 23, 2021
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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