510(k) K061113
K061113 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "ORTHOMON". The FDA issued a decision of Substantially Equivalent on May 23, 2006. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2006
- Date Received
- April 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type