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 |