510(k) K033052
K033052 is an FDA 510(k) premarket notification submitted by Compumedics USA, Ltd. for the device "CONDUCTIVE EEG ELECTROLYTE". The FDA issued a decision of Substantially Equivalent on December 17, 2003. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Compumedics USA, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2003
- Date Received
- September 29, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type