CONDUCTIVE EEG ELECTROLYTE
FDA 510(k) clearance K033052 · decided 2003-12-17
Clearance details
- K-number
- K033052
- Device name
- CONDUCTIVE EEG ELECTROLYTE
- Applicant
- Compumedics USA, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-29
- Decision date
- 2003-12-17
- Days to decision
- 79 days
- Clearance type
- Abbreviated
- Product code
- GYB
- Device class
- 2
- Regulation number
- 882.1275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- El Paso, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.