510(k) K072016
K072016 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE". The FDA issued a decision of Substantially Equivalent on October 19, 2007. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Technomed Europe has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2007
- Date Received
- July 23, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type