Device Classification Name |
Oximeter
|
510(k) Number |
K140785 |
Device Name |
PULSE OXIMETER |
Applicant |
NONIN MEDICAL, INC. |
13700 1ST AVE, NORTH |
Plymouth,
MN
55441
|
|
Applicant Contact |
BRODIE PEDERSEN |
Correspondent |
NONIN MEDICAL, INC. |
13700 1ST AVE, NORTH |
Plymouth,
MN
55441
|
|
Correspondent Contact |
BRODIE PEDERSEN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/31/2014 |
Decision Date | 07/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|