Panels › Anesthesiology › Product code CCL · Class 2
Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation 868.1720
1510(k)s in 12 months (122 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
Top companies in CCL
| Company | 510(k)s | Recalls |
|---|---|---|
| Maxtec, Inc. | 5 | 0 |
| Salter Labs | 5 | 0 |
| Catalyst Research Corp. | 4 | 0 |
| Ceramatec, Inc. | 4 | 0 |
| GE Healthcare | 1 | 3 |
| Teledyne Analytical Instruments | 3 | 1 |
| Vascular Technology Incorporated | 4 | 0 |
| Analytical Industries, Inc. | 3 | 0 |
| Hewlett-Packard Co. | 3 | 0 |
| Bio-Med Devices, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2015 | GE Healthcare D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors.
Product Usage:
Water traps are intended to protect the Terminated |
CCL | K051092 |
| Sep 9, 2014 | GE Healthcare, LLC CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units.
The affected modules could be in use with any Terminated |
CCL | K123195 K133576 |
| Jun 17, 2014 | GE Healthcare, LLC GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respi Terminated |
CCL | K051092 |
| Dec 29, 2009 | Teleflex Medical Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709 Terminated |
CCL | None listed |
| Jul 20, 2004 | Teledyne Analytical Instruments Portable Oxygen Analyzer Terminated |
CCL | None listed |
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