EVOKED POTENTIAL SYSTEM-1.0
FDA 510(k) clearance K932994 · decided 1996-04-15
Clearance details
- K-number
- K932994
- Device name
- EVOKED POTENTIAL SYSTEM-1.0
- Applicant
- Neuromedical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-18
- Decision date
- 1996-04-15
- Days to decision
- 1032 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chesterland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.