Panels › Anesthesiology › Product code FLS · Class 2
Monitor, Apnea, Facility Use
Regulation 868.2377
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FLS
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics, Inc. | 0 | 2 |
| Air-Shields, Inc. | 1 | 0 |
| Airsep Corp. | 1 | 0 |
| Alternative Design Systems, Inc. | 1 | 0 |
| Burr Engineering & Development Co. | 1 | 0 |
| Clinical Data, Inc. | 1 | 0 |
| Douglas Scientific Products | 1 | 0 |
| Hogan & Hartson | 1 | 0 |
| Ilife Systems, Inc. | 1 | 0 |
| Litton Medical Electronics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2002 | K011597 | SMARTMONITOR 2, MODEL 4000 Respironics Georgia, Inc. | FLS |
| Jan 12, 2000 | K991087 | HANNAH WIRELESS VITAL SIGNS MONITOR Ilife Systems, Inc. | FLS |
| Oct 25, 1996 | K962865 | REMBRANDT SYSTEM Airsep Corp. | FLS |
| Feb 2, 1996 | K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS Protocol Systems, Inc. | FLS |
| Oct 30, 1989 | K894973 | RESPITRACE PLUS Hogan & Hartson | FLS |
| Feb 13, 1984 | K832999 | RESPIRATION MONITOR Litton Medical Electronics | FLS |
| Oct 14, 1983 | K830778 | MONITORING KIT AMK-1 Alternative Design Systems, Inc. | FLS |
| Oct 6, 1982 | K822077 | RESPIRATION MONITOR TYPE MR-10 New Dimensions IN Medicine, Inc. | FLS |
| Jul 13, 1982 | K821721 | CLINICAL DATA APNEA DETECTOR Clinical Data, Inc. | FLS |
| May 3, 1982 | K820943 | SYSTEM I INFANT MONITORING SYS Burr Engineering & Development Co. | FLS |
| Feb 9, 1981 | K810153 | VENTILATORY EFFORT MONITOR Medicon, Inc. | FLS |
| Nov 12, 1980 | K802710 | INFANT APNEA MONITOR Douglas Scientific Products | FLS |
| Apr 10, 1980 | K800164 | 413A NEONATAL MONITOR Xerox Corp. | FLS |
| Aug 10, 1978 | K781216 | INFUSION CONTROLLER, PARENTERAL National Patent Development Corp. | FLS |
| Sep 21, 1976 | K760635 | MEDI-DYNE APNEA MONITOR Med Dyne Inst., Inc. | FLS |
| Sep 21, 1976 | K760104 | RESPIRATION MONITOR Air-Shields, Inc. | FLS |
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