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Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
FDA product code KLK · Class 2 · Anesthesiology
111
Registered devices
16
Adverse events
3
Recalls
47
510(k) clearances
Devices with this code
TC sensor, Fixation kit — Radiometer Medical ApSContact Gel — SenTec AGPSG Cable C — SenTec AGPSG Cable L — SenTec AGPSG-X — SenTec AGTCM4 combi module, TCpO2/O2 combi module — Radiometer Medical ApSPSG Cable E — SenTec AGPSG Cable K — SenTec AGNeonatal Starter Set (without Service Gas) — SenTec AGtc Sensor 54 — Radiometer Medical ApSPSG Cable D — SenTec AGTC pO2/pCO2 electrode — Radiometer Medical ApSV-STATS™ Installation CD — SenTec AG103422 Sensor Adapter Cable (Extra Long) — SenTec AGCOMBI *M sensor 82 — Radiometer Basel AGMulti-Site Attachment Ring for mature/intact skin — SenTec AGFixation Kit For TC electrodes — Radiometer Medical ApSPSG Cable J — SenTec AGTCM4x Cable — Radiometer Medical ApSEar Clip — SenTec AGPSG Cable A — SenTec AGNon-Adhesive Wrap — SenTec AGNA — Philips Medizin Systeme Böblingen GmbHTC 560 Contact Liquid — Perimed AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-07 | Radiometer America Inc | System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further. |
| 2005-11-01 | Radiometer America Inc | Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations |
| 2005-02-02 | Radiometer America Inc | Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped. |
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