TIGER PULSE
FDA 510(k) clearance K830325 · decided 1983-03-01
Clearance details
- K-number
- K830325
- Device name
- TIGER PULSE
- Applicant
- Bertone & Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-01
- Decision date
- 1983-03-01
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GZK
- Device class
- 2
- Regulation number
- 882.1340
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BALL RECORDING ELECTRODE/STIMULATION PROBE (K030517) | Viasys Healthcare, Inc. | 2003-08-01 |
Recalls involving this device
No recalls on record reference this clearance.