CUEVA CRANIAL NERVE ELECTRODE
FDA 510(k) clearance K944061 · decided 1995-01-20
Clearance details
- K-number
- K944061
- Device name
- CUEVA CRANIAL NERVE ELECTRODE
- Applicant
- Ad-Tech Medical Instrument Corp
- Decision
- Substantially Equivalent
- Date received
- 1994-08-19
- Decision date
- 1995-01-20
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Racine, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: recall (Z-0106-2015) | Ad-Tech Medical Instrument Corporation | 2014-10-21 |