510(k) K053214
K053214 is an FDA 510(k) premarket notification submitted by Neurotron Medical for the device "THERAKNIT GARMENT ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 20, 2005. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Neurotron Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2005
- Date Received
- November 17, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type