The following data is part of a premarket notification filed by Ems Industries, Inc. with the FDA for Austin Inhalator.
| Device ID | K823246 |
| 510k Number | K823246 |
| Device Name: | AUSTIN INHALATOR |
| Classification | Tubing, Pressure And Accessories |
| Applicant | EMS INDUSTRIES, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-01 |
| Decision Date | 1982-12-16 |