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 |