The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Micro-air Vibrating Mesh Nebulizer, Model Ne-u22.
| Device ID | K062263 |
| 510k Number | K062263 |
| Device Name: | OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Ranndy Kellogg |
| Correspondent | Ranndy Kellogg OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2007-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796512255 | K062263 | 000 |
| 10073796011038 | K062263 | 000 |
| 10073796011045 | K062263 | 000 |
| 10073796011052 | K062263 | 000 |
| 10073796451001 | K062263 | 000 |
| 00073796451226 | K062263 | 000 |
| 00073796512217 | K062263 | 000 |
| 00073796512224 | K062263 | 000 |
| 00073796512231 | K062263 | 000 |
| 00073796512248 | K062263 | 000 |
| 10073796011021 | K062263 | 000 |