BALL RECORDING ELECTRODE/STIMULATION PROBE
FDA 510(k) clearance K030517 · decided 2003-08-01
Clearance details
- K-number
- K030517
- Device name
- BALL RECORDING ELECTRODE/STIMULATION PROBE
- Applicant
- Viasys Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-19
- Decision date
- 2003-08-01
- Days to decision
- 163 days
- Clearance type
- Abbreviated
- Product code
- GZK
- Device class
- 2
- Regulation number
- 882.1340
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TIGER PULSE (K830325) | Bertone & Assoc. | 1983-03-01 |
Recalls involving this device
No recalls on record reference this clearance.