The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Omron Ultrasonic Nebulizer Ne-u06.
| Device ID | K875134 |
| 510k Number | K875134 |
| Device Name: | OMRON ULTRASONIC NEBULIZER NE-U06 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | NIDEK, INC. 2706 SOUTH 19TH ST. Birmingham, AL 35209 |
| Contact | Anand Chitlangia |
| Correspondent | Anand Chitlangia NIDEK, INC. 2706 SOUTH 19TH ST. Birmingham, AL 35209 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-12-05 |