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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K110124
Device Name FETAL DOPPLER JPD-100S
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact DIANA HONG
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/18/2011
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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