INTERX5000
FDA 510(k) clearance K042912 · decided 2005-05-17
Clearance details
- K-number
- K042912
- Device name
- INTERX5000
- Applicant
- Neuro Resource Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-21
- Decision date
- 2005-05-17
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and recall (Z-2105-2011) | Neuro Resource Group Inc | 2011-04-28 |