510(k) K070259
K070259 is an FDA 510(k) premarket notification submitted by Bedfont Scientific, Ltd. for the device "EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR". The FDA issued a decision of Substantially Equivalent on February 21, 2008. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Bedfont Scientific, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2008
- Date Received
- January 26, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1430
- Review Panel
- AN
- Submission Type