Disposable Monopolar and Bipolar Stimulator Probes
FDA 510(k) K062996 · Axon Systems, Inc.
510(k) numberK062996
Submission
- Device name
- Disposable Monopolar and Bipolar Stimulator Probes
- Applicant
- Axon Systems, Inc.
Hauppauge, NY, US - Received
- October 2, 2006
- Decision date
- January 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Disposable Monopolar and Bipolar Stimulator Probes cleared by the FDA?
Disposable Monopolar and Bipolar Stimulator Probes (K062996) received a 510(k) decision of Substantially Equivalent on January 12, 2007, 102 days after the submission was received.
What is the product code of K062996?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.