510(k) K142769
- Device
- Fetal Doppler
- Applicant
- ICare Newlife Technologies, Inc.
- 510(k) number
- K142769
- Product code
- HEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-20
- Date received
- 2014-09-25
- Regulation
- 884.2660
- Classification name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BO XIAO
- Address
- Wangjing Science Pioneer Park, Suite E-510a, Chaoyang Beijing CN 100102 100102
FDA Registration Numbers#
- 3020115
- 1216677
Source Documents#
Other 510(k) Records For Product Code HEK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Summit Doppler Systems, Inc. | 2006-04-10 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | 1990-10-22 |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | 1988-12-15 |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Terumo America, Inc. | 1977-07-14 |
Legacy Summary#
summary
FDA Review#
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