FLS · Monitor, Apnea, Facility Use
Anesthesiology · 21 CFR 868.2377 · Class 2
Overview
| Product Code | FLS |
|---|---|
| Device Name | Monitor, Apnea, Facility 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.”
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011597 | SMARTMONITOR 2, MODEL 4000 | Respironics Georgia, Inc. | Jan 11, 2002 | SESE |
| K991087 | HANNAH WIRELESS VITAL SIGNS MONITOR | Ilife Systems, Inc. | Jan 12, 2000 | ST |
| K962865 | REMBRANDT SYSTEM | Airsep Corp. | Oct 25, 1996 | ST |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | Protocol Systems, Inc. | Feb 2, 1996 | ST |
| K894973 | RESPITRACE PLUS | Hogan & Hartson | Oct 30, 1989 | SESE |
| K832999 | RESPIRATION MONITOR | Litton Medical Electronics | Feb 13, 1984 | SESE |
| K830778 | MONITORING KIT AMK-1 | Alternative Design Systems, Inc. | Oct 14, 1983 | SESE |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | New Dimensions IN Medicine, Inc. | Oct 6, 1982 | SESE |
| K821721 | CLINICAL DATA APNEA DETECTOR | Clinical Data, Inc. | Jul 13, 1982 | SESE |
| K820943 | SYSTEM I INFANT MONITORING SYS | Burr Engineering & Development Co. | May 3, 1982 | SESE |
| K810153 | VENTILATORY EFFORT MONITOR | Medicon, Inc. | Feb 9, 1981 | SESE |
| K802710 | INFANT APNEA MONITOR | Douglas Scientific Products | Nov 12, 1980 | SESE |
| K800164 | 413A NEONATAL MONITOR | Xerox Corp. | Apr 10, 1980 | SESE |
| K781216 | INFUSION CONTROLLER, PARENTERAL | National Patent Development Corp. | Aug 10, 1978 | SESE |
| K760635 | MEDI-DYNE APNEA MONITOR | Med Dyne Inst., Inc. | Sep 21, 1976 | SESE |
| K760104 | RESPIRATION MONITOR | Air-Shields, Inc. | Sep 21, 1976 | SESE |
Top Applicants
- Xerox Corp. — 1 clearance
- Respironics Georgia, Inc. — 1 clearance
- Protocol Systems, Inc. — 1 clearance
- New Dimensions IN Medicine, Inc. — 1 clearance
- National Patent Development Corp. — 1 clearance
