FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Spes Medica Subdermal Needle Electrodes
K Number: K192603
·
Decision Nov 22, 2019
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
9
Review Days
63
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Basic Information
- Device Name
- Spes Medica Subdermal Needle Electrodes
- K Number
- K192603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spes Medica Srl
- Date Received
- September 20, 2019
- Decision Date
- November 22, 2019
- Product Code
- GXZ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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Other Clearances by Spes Medica Srl
| K Number | Device Name | ||
|---|---|---|---|
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Nov 10, 2022 | Substantially Equivalent |
| K212326 | AC Cream - Conductive paste | Dec 1, 2021 | Substantially Equivalent |
| K192606 | SAC2 - Electrode Cream | Jan 17, 2020 | Substantially Equivalent |
| K190050 | Tech Dots - Adhesive and conductive gel | Jul 19, 2019 | Substantially Equivalent |
| K133348 | STIM PROBE | Nov 21, 2014 | Substantially Equivalent |
| K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE | Jun 11, 2012 | Substantially Equivalent |
| K093373 | LARYNGEAL SURFACE ELECTRODE | Aug 24, 2010 | Substantially Equivalent |
| K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | Aug 11, 2009 | Substantially Equivalent |