The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Technison Axon System.
| Device ID | K941156 |
| 510k Number | K941156 |
| Device Name: | TECHNISON AXON SYSTEM |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca Jr. |
| Correspondent | Gabriel J Muraca Jr. MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-10 |
| Decision Date | 1994-04-26 |