QUANTITATIVE EEG ANALYSIS SOFTWARE
FDA 510(k) clearance K951724 · decided 1995-07-14
Clearance details
- K-number
- K951724
- Device name
- QUANTITATIVE EEG ANALYSIS SOFTWARE
- Applicant
- Neuroconcepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-14
- Decision date
- 1995-07-14
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- OLT
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Middleton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.