CLINICAL DATA APNEA DETECTOR
Device Facts
| Record ID | K821721 |
|---|---|
| Device Name | CLINICAL DATA APNEA DETECTOR |
| Applicant | Clinical Data, Inc. |
| Product Code | FLS · Anesthesiology |
| Decision Date | Jul 13, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2377 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
