Device Classification Name |
oximeter, tissue saturation
|
510(k) Number |
K122645 |
Device Name |
MOBILE CAREGUIDE 2100 OXIMETER |
Applicant |
REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, |
SUITE 1000 |
WESTBOROUGH,
MA
01581
|
|
Applicant Contact |
Nandini Murthy |
Correspondent |
REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, |
SUITE 1000 |
WESTBOROUGH,
MA
01581
|
|
Correspondent Contact |
Nandini Murthy |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/30/2012 |
Decision Date | 12/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|