510(k) K970943
K970943 is an FDA 510(k) premarket notification submitted by Axon Instruments, Inc. for the device "GUIDELINE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 18, 1997. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Axon Instruments, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1997
- Date Received
- March 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type