MIND MAP (20 CHANNEL EEG)
FDA 510(k) clearance K860378 · decided 1986-08-12
Clearance details
- K-number
- K860378
- Device name
- MIND MAP (20 CHANNEL EEG)
- Applicant
- Mind Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-03
- Decision date
- 1986-08-12
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- OLT
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.