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
- 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 |