The following data is part of a premarket notification filed by Bedfont Scientific Ltd. with the FDA for Pico Smokerlyzer, Model Ec-50.
| Device ID | K000962 |
| 510k Number | K000962 |
| Device Name: | PICO SMOKERLYZER, MODEL EC-50 |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | BEDFONT SCIENTIFIC LTD. BEDFONT HOUSE HOLYWELL LANE Upchurch, Kent, GB Me9 7hn |
| Contact | Martin Foxley |
| Correspondent | Martin Foxley BEDFONT SCIENTIFIC LTD. BEDFONT HOUSE HOLYWELL LANE Upchurch, Kent, GB Me9 7hn |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-04-20 |