Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical Electrode
FDA 510(k) K964224 · Pmt Corp.
510(k) numberK964224
Submission
- Device name
- Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical Electrode
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- October 23, 1996
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical Electrode cleared by the FDA?
Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical Electrode (K964224) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 147 days after the submission was received.
What is the product code of K964224?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.