Neuro N100 Radiofrequency Generator and Accessory Cables
FDA 510(k) K010969 · Stryker Instruments
510(k) numberK010969
Submission
- Device name
- Neuro N100 Radiofrequency Generator and Accessory Cables
- Applicant
- Stryker Instruments
Kalamazoo, MI, US - Received
- April 2, 2001
- Decision date
- April 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Neuro N100 Radiofrequency Generator and Accessory Cables cleared by the FDA?
Neuro N100 Radiofrequency Generator and Accessory Cables (K010969) received a 510(k) decision of Substantially Equivalent on April 20, 2001, 18 days after the submission was received.
What is the product code of K010969?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.