FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K Number: K073532
·
Decision May 1, 2008
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
13
Review Days
136
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
- K Number
- K073532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technomed Europe
- Date Received
- December 17, 2007
- Decision Date
- May 1, 2008
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Brain Monitor Headband
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Technomed Europe
| K Number | Device Name | ||
|---|---|---|---|
| K254183 | MR Conditional Cup Electrodes | May 7, 2026 | Substantially Equivalent |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | Mar 15, 2026 | Substantially Equivalent |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Dec 11, 2024 | Substantially Equivalent |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Jul 19, 2013 | Substantially Equivalent |
| K121257 | LARYNGEAL ELECTRODE | Aug 28, 2012 | Substantially Equivalent |
| K110422 | SURGICAL STIMULATORS | May 26, 2011 | Substantially Equivalent |
| K072016 | CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE | Oct 19, 2007 | Substantially Equivalent |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Aug 21, 2007 | Substantially Equivalent |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | Feb 16, 2007 | Substantially Equivalent |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE | May 5, 2005 | Substantially Equivalent |