RECORDING AND STIMULATING ELECTRODE
FDA 510(k) clearance K012850 · decided 2001-11-19
Clearance details
- K-number
- K012850
- Device name
- RECORDING AND STIMULATING ELECTRODE
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Decision
- Substantially Equivalent
- Date received
- 2001-08-24
- Decision date
- 2001-11-19
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.