The following data is part of a premarket notification filed by Md Diagnostics Limited with the FDA for Co Check Pro, Co Screen.
| Device ID | K171129 |
| 510k Number | K171129 |
| Device Name: | CO Check Pro, CO Screen |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | MD Diagnostics Limited 15 Hollingworth Court, Turkey Mill Maidstone, GB Me14 5pp |
| Contact | Glen Hillsley |
| Correspondent | Glen Hillsley MD Diagnostics Limited 15 Hollingworth Court, Turkey Mill Maidstone, GB Me14 5pp |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2018-03-02 |
| Summary: | summary |