Monitor, Heart Sound, Fetal, Ultrasonic
The Fetal Ultrasonic Heart Sound Monitor is a non-invasive device that uses ultrasound to detect and transmit the acoustic sounds of the fetal heartbeat for monitoring fetal wellbeing during pregnancy or labor. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEK, regulated under 21 CFR 884.2660, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- HEK
- Device Class
- FDA class 2
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142769 | Fetal Doppler | Mar 20, 2015 | Substantially Equivalent | iCare Newlife Technologies, Inc. |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Apr 10, 2006 | Substantially Equivalent | SUMMIT DOPPLER SYSTEMS, INC. |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Oct 22, 1990 | Substantially Equivalent | ADVANCED MEDICAL SYSTEMS, INC. |
| K883334 | BIODOP(TM) | Dec 15, 1988 | Substantially Equivalent | DIAGNOSIS RELATED SYSTEMS, INC. |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Jul 14, 1977 | Substantially Equivalent | TERUMO AMERICA, INC. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.