FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
EC50 MICRO+ SMOKERLYZER
K Number: K082315
·
Decision Feb 1, 2010
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
6
Review Days
537
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Basic Information
- Device Name
- EC50 MICRO+ SMOKERLYZER
- K Number
- K082315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bedfont Scientific, Ltd.
- Date Received
- August 13, 2008
- Decision Date
- February 1, 2010
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Bedfont Scientific, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Dec 21, 2021 | Substantially Equivalent |
| K203695 | NObreath® | Dec 17, 2021 | Substantially Equivalent |
| K173238 | ToxCO | Apr 4, 2019 | 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 |