The following data is part of a premarket notification filed by Bedfont Scientific Ltd. with the FDA for Ec50 Toxco+ Breath Carbon Monoxide Monitor.
| Device ID | K070259 |
| 510k Number | K070259 |
| Device Name: | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | BEDFONT SCIENTIFIC LTD. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2008-02-21 |
| Summary: | summary |