510(k) K082629
K082629 is an FDA 510(k) premarket notification submitted by Chatten Associates, Inc. for the device "S12X WITH ESAX OPTION". The FDA issued a decision of Substantially Equivalent on July 1, 2009. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2009
- Date Received
- September 9, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type