Fetal Doppler
FDA 510(k) clearance K142769 · decided 2015-03-20
Clearance details
- K-number
- K142769
- Device name
- Fetal Doppler
- Applicant
- Icare Newlife Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-25
- Decision date
- 2015-03-20
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- HEK
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Beijing, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ECHOHEART TRANSVAGINAL DOPPLER PROBE (K060410) | Summit Doppler Systems, Inc. | 2006-04-10 |
| FETAL PULSE DETECTOR MODEL DOP-1 (K902190) | Advanced Medical Systems, Inc. | 1990-10-22 |
| BIODOP(TM) (K883334) | Diagnosis Related Systems, Inc. | 1988-12-15 |
| DOPPLER (UTD-5 & UTD-6) (K771211) | Terumo America, Inc. | 1977-07-14 |
Recalls involving this device
No recalls on record reference this clearance.