Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K122438 |
Device Name |
HAMILTON-MR1 |
Applicant |
HAMILTON MEDICAL AG |
VIA CRUSCH 8 |
BONADUZ,
CH
CH-7402
|
|
Applicant Contact |
RALPH AGUILA |
Correspondent |
HAMILTON MEDICAL AG |
VIA CRUSCH 8 |
BONADUZ,
CH
CH-7402
|
|
Correspondent Contact |
RALPH AGUILA |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 08/10/2012 |
Decision Date | 11/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|