Device Classification Name |
Oximeter
|
510(k) Number |
K093306 |
Device Name |
SINGLE-PATIENT USE DISPOSABLE SENSOR |
Applicant |
NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH |
PLYMOUTH,
MN
55441 -5443
|
|
Applicant Contact |
LORI ROTH |
Correspondent |
NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH |
PLYMOUTH,
MN
55441 -5443
|
|
Correspondent Contact |
LORI ROTH |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/22/2009 |
Decision Date | 03/04/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|