GROUND/REFERENCE NEEDLE ELECTRODE
FDA 510(k) clearance K933793 · decided 1994-04-19
Clearance details
- K-number
- K933793
- Device name
- GROUND/REFERENCE NEEDLE ELECTRODE
- Applicant
- Cadwell Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-04
- Decision date
- 1994-04-19
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- GXZ
- Device class
- 2
- Regulation number
- 882.1350
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kennewick, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.