SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
FDA 510(k) clearance K083758 · decided 2009-08-14
Clearance details
- K-number
- K083758
- Device name
- SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
- Applicant
- The Electrode Store, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-17
- Decision date
- 2009-08-14
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Port Townsend, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.