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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 K082055
Device Name MODEL PC-860 FETAL DOPPLER
Applicant
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou
Tian'An Industry Town
Chenzhen City,  CN 518054
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.2660
Classification Product Code
KNG  
Date Received07/21/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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