510(k) K964224
K964224 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Pmt Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1997
- Date Received
- October 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type