PMT Subdural Cortical Electrodes
FDA 510(k) K082474 · Pmt Corp.
510(k) numberK082474
Submission
- Device name
- PMT Subdural Cortical Electrodes
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- August 28, 2008
- Decision date
- May 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was PMT Subdural Cortical Electrodes cleared by the FDA?
PMT Subdural Cortical Electrodes (K082474) received a 510(k) decision of Substantially Equivalent on May 8, 2009, 253 days after the submission was received.
What is the product code of K082474?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.