FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
K Number: K070259
·
Decision Feb 21, 2008
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
6
Review Days
391
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
- K Number
- K070259
- 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
- January 26, 2007
- Decision Date
- February 21, 2008
- Product Code
- CCJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCJ), ordered by most recent decision date.
CoSense ETCO Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
iCOquit® Smokerlyzer®
FDA 510(k)
FDA Class 2
·Anesthesiology
Pivot Breath Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
ToxCO
FDA 510(k)
FDA Class 2
·Anesthesiology
CO Check Pro, CO Screen
FDA 510(k)
FDA Class 2
·Anesthesiology
Carbon Monoxide Breath Sensor System (COBSS)
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Apr 20, 2000 | Substantially Equivalent |