FLS — Monitor, Apnea, Facility Use Class II
FDA Device Classification
Classification Details
- Product Code
- FLS
- Device Class
- Class II
- Regulation Number
- 868.2377
- Submission Type
- 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 | January 11, 2002 |
| K991087 | ilife systems | HANNAH WIRELESS VITAL SIGNS MONITOR | January 12, 2000 |
| K962865 | airsep | REMBRANDT SYSTEM | October 25, 1996 |
| K951246 | protocol systems | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O | February 2, 1996 |
| K894973 | hogan and hartson | RESPITRACE PLUS | October 30, 1989 |
| K832999 | litton medical electronics | RESPIRATION MONITOR | February 13, 1984 |
| K830778 | alternative design systems | MONITORING KIT AMK-1 | October 14, 1983 |
| K822077 | new dimensions in medicine | RESPIRATION MONITOR TYPE MR-10 | October 6, 1982 |
| K821721 | clinical data | CLINICAL DATA APNEA DETECTOR | July 13, 1982 |
| K820943 | burr engineering and development | SYSTEM I INFANT MONITORING SYS | May 3, 1982 |
| K810153 | medicon | VENTILATORY EFFORT MONITOR | February 9, 1981 |
| K802710 | douglas scientific products | INFANT APNEA MONITOR | November 12, 1980 |
| K800164 | xerox | 413A NEONATAL MONITOR | April 10, 1980 |
| K781216 | national patent development | INFUSION CONTROLLER, PARENTERAL | August 10, 1978 |
| K760635 | med dyne inst | MEDI-DYNE APNEA MONITOR | September 21, 1976 |
| K760104 | air-shields | RESPIRATION MONITOR | September 21, 1976 |