PHILIPS INTELLIVUE TCG10
FDA 510(k) clearance K110474 · decided 2011-09-30
Clearance details
- K-number
- K110474
- Device name
- PHILIPS INTELLIVUE TCG10
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2011-02-18
- Decision date
- 2011-09-30
- Days to decision
- 224 days
- Clearance type
- Abbreviated
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a de recall (Z-0997-2015) | Philips Medical Systems, Inc. | 2015-01-16 |