Neuromap with Neuro 100
FDA 510(k) K002773 · Radionics, Inc.
510(k) numberK002773
Submission
- Device name
- Neuromap with Neuro 100
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- September 6, 2000
- Decision date
- October 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Neuromap with Neuro 100 cleared by the FDA?
Neuromap with Neuro 100 (K002773) received a 510(k) decision of Substantially Equivalent on October 23, 2000, 47 days after the submission was received.
What is the product code of K002773?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.