PHILIPS BV LIBRA
FDA 510(k) clearance K010762 · decided 2001-04-02
Clearance details
- K-number
- K010762
- Device name
- PHILIPS BV LIBRA
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-14
- Decision date
- 2001-04-02
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiograp recall (Z-1603-2011) | Philips Medical Systems North America Co. Phillips | 2011-03-08 |