Model RFG-3C Radiofrequency Lesion Generator
FDA 510(k) K901540 · Radionics, Inc.
510(k) numberK901540
Submission
- Device name
- Model RFG-3C Radiofrequency Lesion Generator
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- April 2, 1990
- Decision date
- April 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Model RFG-3C Radiofrequency Lesion Generator cleared by the FDA?
Model RFG-3C Radiofrequency Lesion Generator (K901540) received a 510(k) decision of Substantially Equivalent on April 8, 1991, 371 days after the submission was received.
What is the product code of K901540?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.