510(k) K845035
K845035 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "ELECTRODE FOR NEUROLOGICAL SURGERY 2111". The FDA issued a decision of SN on July 30, 1985. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Progress Mankind Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- July 30, 1985
- Date Received
- December 27, 1984
- 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