The following data is part of a premarket notification filed by Axon Instruments, Inc. with the FDA for Guideline System.
| Device ID | K970943 |
| 510k Number | K970943 |
| Device Name: | GUIDELINE SYSTEM |
| Classification | Electrode, Depth |
| Applicant | AXON INSTRUMENTS, INC. 1101 CHESS DR. Foster City, CA 94404 -1102 |
| Contact | Andrew L Blatz |
| Correspondent | Andrew L Blatz AXON INSTRUMENTS, INC. 1101 CHESS DR. Foster City, CA 94404 -1102 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-08-18 |