STERILE SUBDERMAL NEEDLE ELECTRODES
FDA 510(k) clearance K010019 · decided 2001-03-19
Clearance details
- K-number
- K010019
- Device name
- STERILE SUBDERMAL NEEDLE ELECTRODES
- Applicant
- Nicolet Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-02
- Decision date
- 2001-03-19
- Days to decision
- 76 days
- Clearance type
- Abbreviated
- Product code
- GXZ
- Device class
- 2
- Regulation number
- 882.1350
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Man recall (Z-1254-06) | Nicolet Biomedical Div of Viasys Healthcare | 2006-07-25 |