The following data is part of a premarket notification filed by Md Diagnostics Limited with the FDA for Safebreath Filter Mouthpiece.
| Device ID | K190022 |
| 510k Number | K190022 |
| Device Name: | SafeBreath Filter Mouthpiece |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-04 |
| Decision Date | 2019-09-25 |
| Summary: | summary |