510(k) K092729
K092729 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "BAXANO NEURO CHECK DEVICE". The FDA issued a decision of Substantially Equivalent on October 2, 2009. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Baxano, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2009
- Date Received
- September 4, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type