The following data is part of a premarket notification filed by Axon Medical with the FDA for Anefin, Model 100.
| Device ID | K033028 |
| 510k Number | K033028 |
| Device Name: | ANEFIN, MODEL 100 |
| Classification | Apparatus, Gas-scavenging |
| Applicant | AXON MEDICAL 2355 SOUTH 1170 WEST SUITE D Salt Lake City, UT 84119 |
| Contact | Joseph Orr |
| Correspondent | Joseph Orr AXON MEDICAL 2355 SOUTH 1170 WEST SUITE D Salt Lake City, UT 84119 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2005-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10863034000326 | K033028 | 000 |