Pocket Fetal Doppler (Models CONTEC10C And CONTEC10CL)

Monitor, Ultrasonic, Fetal

Contec Medical Systems Co., Ltd.

The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Pocket Fetal Doppler (models Contec10c And Contec10cl).

Pre-market Notification Details

Device IDK220245
510k NumberK220245
Device Name:Pocket Fetal Doppler (Models CONTEC10C And CONTEC10CL)
ClassificationMonitor, Ultrasonic, Fetal
Applicant Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone Qinhuangdao,  CN
ContactJie Xiao
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeKNG  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-28
Decision Date2022-09-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945040105411 K220245 000
06945040105404 K220245 000

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