The following data is part of a premarket notification filed by Bedfont Scientific Ltd. with the FDA for Ec50 Micro+ Smokerlyzer.
| Device ID | K082315 |
| 510k Number | K082315 |
| Device Name: | EC50 MICRO+ SMOKERLYZER |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | BEDFONT SCIENTIFIC LTD. 105 LAKER RD. Rochester, Kent, GB Me1 3qx |
| Contact | Glen Hillsley |
| Correspondent | Glen Hillsley BEDFONT SCIENTIFIC LTD. 105 LAKER RD. Rochester, Kent, GB Me1 3qx |
| Product Code | CCJ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2010-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060246860047 | K082315 | 000 |