The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Compressor Nebulizer- Model Ne-c09.
| Device ID | K914836 |
| 510k Number | K914836 |
| Device Name: | OMRON COMPRESSOR NEBULIZER- MODEL NE-C09 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Lee A.cabot |
| Correspondent | Lee A.cabot 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 | 1991-10-25 |
| Decision Date | 1992-05-06 |