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510(k) K110124

FETAL DOPPLER JPD-100S by Shenzhen Jumper Medical Equipment Co., Ltd. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2011
Date Received
January 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K140582 — FINGERTIP PULSE OXIMETER (August 28, 2014)
  • K131457 — FETAL ULTRASONIC MONITOR AND ACCESSORIES (January 24, 2014)
  • K131243 — NON-CONTACT INFRARED THERMOMETER (November 12, 2013)

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