TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
FDA 510(k) clearance K093154 · decided 2010-02-05
Clearance details
- K-number
- K093154
- Device name
- TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2009-10-06
- Decision date
- 2010-02-05
- Days to decision
- 122 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixatio recall (Z-2417-2015) | Radiometer America Inc | 2015-08-19 |