TCM40 MONITORING SYSTEM
FDA 510(k) clearance K043003 · decided 2005-03-01
Clearance details
- K-number
- K043003
- Device name
- TCM40 MONITORING SYSTEM
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2004-11-01
- Decision date
- 2005-03-01
- Days to decision
- 120 days
- Clearance type
- Abbreviated
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, recall (Z-1930-2013) | Radiometer America Inc | 2013-08-08 |
| TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device recall (Z-0341-2012) | Radiometer America Inc | 2011-12-01 |