Device Classification Name |
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
|
510(k) Number |
K173865 |
Device Name |
trophon2 |
Applicant |
Nanosonics Limited |
14 Mars Road |
Lane Cove,
AU
2066
|
|
Applicant Contact |
Ruth Cremin |
Correspondent |
Nanosonics Limited |
14 Mars Road |
Lane Cove,
AU
2066
|
|
Correspondent Contact |
Ruth Cremin |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 12/20/2017 |
Decision Date | 04/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|