510(k) K073229
K073229 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology for the device "NERVE MONITORING CABLE". The FDA issued a decision of Substantially Equivalent on June 6, 2008. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Pioneer Surgical Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2008
- Date Received
- November 15, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle
- Device Class
- Class II
- Regulation Number
- 882.1350
- Review Panel
- NE
- Submission Type