QSI 9500
FDA 510(k) clearance K904294 · decided 1991-07-30
Clearance details
- K-number
- K904294
- Device name
- QSI 9500
- Applicant
- Quantified Signal Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-19
- Decision date
- 1991-07-30
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- OLU
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.