Fetal Doppler

Monitor, Heart Sound, Fetal, Ultrasonic

ICare Newlife Technologies, Inc.

The following data is part of a premarket notification filed by Icare Newlife Technologies, Inc. with the FDA for Fetal Doppler.

Pre-market Notification Details

• Device ID: K142769
• 510k Number: K142769
• Device Name: Fetal Doppler
• Classification: Monitor, Heart Sound, Fetal, Ultrasonic
• Applicant: iCare Newlife Technologies, Inc. Wangjing Science Pioneer Park, Suite E-510A, Chaoyang Beijing, CN 100102
• Contact: Bo Xiao
• Correspondent: Mike Gu; Guangzhou Osmunda Medical Device Consulting Co., Ltd 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyun District, CN 510420
• Product Code: HEK
• CFR Regulation Number: 884.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-25
• Decision Date: 2015-03-20
• Summary: summary