COMP A-I-R
Nebulizer (direct Patient Interface)
OMRON HEALTHCARE, INC.
The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Comp A-i-r.
Pre-market Notification Details
| Device ID | K110860 |
| 510k Number | K110860 |
| Device Name: | COMP A-I-R |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE 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 | 2011-03-29 |
| Decision Date | 2011-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796801458 | K110860 | 000 |
| 00073796801106 | K110860 | 000 |
| 00073796458010 | K110860 | 000 |
Trademark Results [COMP A-I-R]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMP A-I-R 79080616 3885680 Live/Registered |
OMRON HEALTHCARE Co., Ltd. 2010-02-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.