510(k) K082474
K082474 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT SUBDURAL CORTICAL ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 8, 2009. 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
- May 8, 2009
- Date Received
- August 28, 2008
- 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