The following data is part of a premarket notification filed by Bedfont Technical Instruments Ltd. with the FDA for Bedfont Ec50 Smokerlyzer Carbon Monoxide Monitor.
| Device ID | K892841 |
| 510k Number | K892841 |
| Device Name: | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | BEDFONT TECHNICAL INSTRUMENTS LTD. BEDFONT HOUSE, HOLYWELL LANE UPCHURCH, SITTINGBOURNE, KENT Me9 7hn England, GB |
| Contact | Smith |
| Correspondent | Smith BEDFONT TECHNICAL INSTRUMENTS LTD. BEDFONT HOUSE, HOLYWELL LANE UPCHURCH, SITTINGBOURNE, KENT Me9 7hn England, GB |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-10-05 |