HGN · Stethoscope, Fetal
Obstetrics/Gynecology · 21 CFR 884.2900 · Class 1
Overview
| Product Code | HGN |
|---|---|
| Device Name | Stethoscope, Fetal |
| Regulation | 21 CFR 884.2900 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813298 | CONPHAR DELEE HILLIS STETHOSCOPE | Conphar, Inc. | Dec 8, 1981 | SESE |
| K761338 | LEFF STETHOSCOPE FOR FETAL HEART | J. Sklar Mfg. Co., Inc. | Jan 12, 1977 | SESE |
Top Applicants
- Conphar, Inc. — 1 clearance
- J. Sklar Mfg. Co., Inc. — 1 clearance
