FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PICO SMOKERLYZER, MODEL EC-50
K Number: K000962
·
Decision Apr 20, 2000
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- PICO SMOKERLYZER, MODEL EC-50
- K Number
- K000962
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bedfont Scientific, Ltd.
- Date Received
- March 24, 2000
- Decision Date
- April 20, 2000
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| 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 |
| K082315 | EC50 MICRO+ SMOKERLYZER | Feb 1, 2010 | Substantially Equivalent |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Feb 21, 2008 | Substantially Equivalent |