NPF · Monitor, Apnea, Home Use
Anesthesiology · 21 CFR 868.2377 · Class 2
Overview
| Product Code | NPF |
|---|---|
| Device Name | Monitor, Apnea, Home Use |
| Regulation | 21 CFR 868.2377 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061256 | SMARTMONITOR 2PS | Respironics, Inc. | Aug 2, 2006 | SESE |
| K032403 | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) | Respironics, Inc. | Oct 27, 2003 | SESE |
Top Applicants
- Respironics, Inc. — 2 clearances
