The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Ne-u04/ne U04f.
| Device ID | K923024 |
| 510k Number | K923024 |
| Device Name: | NE-U04/NE U04F |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Terrence M O'brien |
| Correspondent | Terrence M O'brien OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-23 |
| Decision Date | 1992-09-15 |