EEG SPIKE AND EVENT DETECTOR MODULE
FDA 510(k) clearance K002332 · decided 2000-10-06
Clearance details
- K-number
- K002332
- Device name
- EEG SPIKE AND EVENT DETECTOR MODULE
- Applicant
- Excel Tech. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-01
- Decision date
- 2000-10-06
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- OMB
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakville, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.