The following data is part of a premarket notification filed by Inhalation Therapy Equipment, Co. with the FDA for Ster-o-mist 1000 Ml.
| Device ID | K821191 |
| 510k Number | K821191 |
| Device Name: | STER-O-MIST 1000 ML |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INHALATION THERAPY EQUIPMENT, CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-13 |