VECTORVISION CRANIAL/ENT
FDA 510(k) clearance K023651 · decided 2004-02-17
Clearance details
- K-number
- K023651
- Device name
- VECTORVISION CRANIAL/ENT
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2002-10-30
- Decision date
- 2004-02-17
- Days to decision
- 475 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Heimstetten, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a recall (Z-2209-2008) | Brainlab AG | 2008-09-17 |