510(k) K010019 ยท GXZ Electrode, Needle
STERILE SUBDERMAL NEEDLE ELECTRODES
| Applicant | Nicolet Biomedical, Inc., Stoughton WI, US |
| Decision | Substantially Equivalent, Mar 19, 2001 |
| Received | Jan 2, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2006 | Nicolet Biomedical Div of Viasys Healthcare VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each Terminated |
GXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.