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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 pO2/pCO2 Membraning kit For TC electrode — Radiometer Medical ApSExtension cable For TCM3 electrodes, 3m — Radiometer Medical ApSNA — Philips Medizin Systeme Böblingen GmbHTC 550 Fixation Ring for tcpO2/CO2 — Perimed ABPatient Application Kit with Ear Clip for mature/intact skin — SenTec AGPSG Cable B — SenTec AGPSG Cable C — SenTec AGMulti-Site Attachment Ring for mature/intact skin — SenTec AGEar Clip easy — SenTec AGtc Sensor 54 — Radiometer Medical ApSTCM4x Cable — Radiometer Medical ApSTC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive — Perimed ABElectrolyte 54 — Radiometer Medical ApSMembrane Changer (reloadable) / single unit — SenTec AGContact Gel — SenTec AGElectrolyte 84 — Radiometer Medical ApSNA — Philips Medizin Systeme Böblingen GmbHTC electrode — Radiometer Medical ApSSpirometry Sensor — Philips Medizin Systeme Böblingen GmbHFixation Kit For TC electrodes — Radiometer Medical ApSCalibration Gas — Radiometer Medical ApSPHILIPS Transcutaneous pO2/pCO2 Parameter Module — Philips Medizin Systeme Böblingen GmbHSenTec Digital Monitor (with activated PO2 channel) — SenTec AGTCM 4 series ETX base unit — Radiometer Medical ApS
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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