The following data is part of a premarket notification filed by Axon Medical, Inc. with the FDA for Vapor-clear, Model 100.
| Device ID | K092031 |
| 510k Number | K092031 |
| Device Name: | VAPOR-CLEAR, MODEL 100 |
| Classification | Apparatus, Gas-scavenging |
| Applicant | AXON MEDICAL, INC. 2645 SACKETT DR. Park City, UT 84098 |
| Contact | Joseph Orr |
| Correspondent | Joseph Orr AXON MEDICAL, INC. 2645 SACKETT DR. Park City, UT 84098 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-07-06 |
| Decision Date | 2010-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80858545007017 | K092031 | 000 |
| 80858545007000 | K092031 | 000 |