HFP · Monitor, Phonocardiographic, Fetal
Obstetrics/Gynecology · 21 CFR 884.2640 · Class 2
Overview
| Product Code | HFP |
|---|---|
| Device Name | Monitor, Phonocardiographic, Fetal |
| Regulation | 21 CFR 884.2640 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
