Disposable Adhesive Surface Electrodes, Disc Electrodes
FDA 510(k) K073532 · Technomed Europe
510(k) numberK073532
Submission
- Device name
- Disposable Adhesive Surface Electrodes, Disc Electrodes
- Applicant
- Technomed Europe
Maastricht-Airport, NL - Received
- December 17, 2007
- Decision date
- May 1, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
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| K110422 | Surgical StimulatorsETN · Traditional | 05/26/2011SE |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…GXY · Traditional | 10/19/2007SE |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional | 08/21/2007SE |
| K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledIKT · Traditional | 02/16/2007SE |
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Questions and answers
When was Disposable Adhesive Surface Electrodes, Disc Electrodes cleared by the FDA?
Disposable Adhesive Surface Electrodes, Disc Electrodes (K073532) received a 510(k) decision of Substantially Equivalent on May 1, 2008, 136 days after the submission was received.
What is the product code of K073532?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.