510(k) K043009
K043009 is an FDA 510(k) premarket notification submitted by Jordan Neuroscience, Inc. for the device "BRAINET KIT". The FDA issued a decision of Substantially Equivalent on January 12, 2005. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Jordan Neuroscience, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2005
- Date Received
- November 1, 2004
- 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