AQUINOX
Humidifier, Respiratory Gas, (direct Patient Interface)
SMITHS MEDICAL ASD, INC.
The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Aquinox.
Pre-market Notification Details
| Device ID | K050314 |
| 510k Number | K050314 |
| Device Name: | AQUINOX |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SMITHS MEDICAL ASD, INC. ONE MADISON ST. Wampsville, NY 13163 |
| Contact | David Gray |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-02-18 |
| Summary: | summary |
Trademark Results [AQUINOX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUINOX 79331055 not registered Live/Pending |
Xaar Plc 2021-11-25 |
 AQUINOX 78519856 3131030 Dead/Cancelled |
Smiths Medical ASD, Inc. 2004-11-19 |
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