Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K052863 |
Device Name |
RAPHAEL COLOR |
Applicant |
HAMILTON MEDICAL AG |
VIA NOVA |
RHAEZUENS,
CH
CH-7403
|
|
Applicant Contact |
CURDIN DANUSER |
Correspondent |
HAMILTON MEDICAL AG |
VIA NOVA |
RHAEZUENS,
CH
CH-7403
|
|
Correspondent Contact |
CURDIN DANUSER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 10/11/2005 |
Decision Date | 01/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|