FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
NObreath®
K Number: K203695
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
6
Review Days
364
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Basic Information
- Device Name
- NObreath®
- K Number
- K203695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3080
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bedfont Scientific, Ltd.
- Date Received
- December 18, 2020
- Decision Date
- December 17, 2021
- Product Code
- MXA
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | FDA class 2 | Clinical Toxicology |
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Other Clearances by Bedfont Scientific, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Dec 21, 2021 | Substantially Equivalent |
| K173238 | ToxCO | Apr 4, 2019 | Substantially Equivalent |
| K082315 | EC50 MICRO+ SMOKERLYZER | Feb 1, 2010 | Substantially Equivalent |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Feb 21, 2008 | Substantially Equivalent |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Apr 20, 2000 | Substantially Equivalent |