Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K190022 |
Device Name |
SafeBreath Filter Mouthpiece |
Applicant |
MD Diagnostics Limited |
15 Hollingworth Court, Turkey Mill |
Maidstone,
GB
ME14 5pp
|
|
Applicant Contact |
Glen Hillsley |
Correspondent |
MD Diagnostics Limited |
15 Hollingworth Court, Turkey Mill |
Maidstone,
GB
ME14 5pp
|
|
Correspondent Contact |
Glen Hillsley |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 01/04/2019 |
Decision Date | 09/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|