21 CFR 884.2050 — Analyzer, Data, Obstetric
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2050
Identification
An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic interfaces for other equipment, and power supplies and component parts.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HEO | Analyzer, Data, Obstetric | 3 | 1 |
