FLS — Monitor, Apnea, Facility Use Class II
FDA product code FLS covers "Monitor, Apnea, Facility Use", a Class II medical device regulated under 21 CFR 868.2377. Submissions are reviewed by the Anesthesiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FLS
- Device Class
- Class II
- Regulation Number
- 868.2377
- Submission Type
- 510(k)
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011597 | Respironics Georgia | SMARTMONITOR 2, MODEL 4000 | Jan 11, 2002 |
| K991087 | Ilife Systems | HANNAH WIRELESS VITAL SIGNS MONITOR | Jan 12, 2000 |
| K962865 | Airsep | REMBRANDT SYSTEM | Oct 25, 1996 |
| K951246 | Protocol Systems | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY… | Feb 2, 1996 |
| K894973 | Hogan And Hartson | RESPITRACE PLUS | Oct 30, 1989 |
| K832999 | Litton Medical Electronics | RESPIRATION MONITOR | Feb 13, 1984 |
| K830778 | Alternative Design Systems | MONITORING KIT AMK-1 | Oct 14, 1983 |
| K822077 | New Dimensions In Medicine | RESPIRATION MONITOR TYPE MR-10 | Oct 6, 1982 |
| K821721 | Clinical Data | CLINICAL DATA APNEA DETECTOR | Jul 13, 1982 |
| K820943 | Burr Engineering And Development | SYSTEM I INFANT MONITORING SYS | May 3, 1982 |
| K810153 | Medicon | VENTILATORY EFFORT MONITOR | Feb 9, 1981 |
| K802710 | Douglas Scientific Products | INFANT APNEA MONITOR | Nov 12, 1980 |
| K800164 | Xerox | 413A NEONATAL MONITOR | Apr 10, 1980 |
| K781216 | National Patent Development | INFUSION CONTROLLER, PARENTERAL | Aug 10, 1978 |
| K760104 | Air-Shields | RESPIRATION MONITOR | Sep 21, 1976 |
| K760635 | Med Dyne Inst | MEDI-DYNE APNEA MONITOR | Sep 21, 1976 |