21 CFR 868.2377 — Monitor, Apnea, Facility Use
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2377
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FLS | Monitor, Apnea, Facility Use | 2 | 16 | Life-Sustaining |
| NPF | Monitor, Apnea, Home Use | 2 | 2 | Life-Sustaining |
Special Controls
FLS — Monitor, Apnea, Facility Use
*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.”
eCFR
FLS — Monitor, Apnea, Facility Use
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.”
Ecfr Llm
NPF — Monitor, Apnea, Home Use
*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.”
eCFR
