NObreath®
System, Test, Breath Nitric Oxide
Bedfont Scientific Ltd
The following data is part of a premarket notification filed by Bedfont Scientific Ltd with the FDA for Nobreath®.
Pre-market Notification Details
| Device ID | K203695 |
| 510k Number | K203695 |
| Device Name: | NObreath® |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | Bedfont Scientific Ltd Station Road, Harrietsham Maidstone, Kent, GB Me17 1ja |
| Contact | Louise Bateman |
| Correspondent | Paul Dryden Bedfont Scientific, LLC C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-12-17 |
Trademark Results [NObreath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBREATH 79198583 5382851 Live/Registered |
Bedfont Scientific Limited 2016-07-07 |
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