Device Classification Name |
Oximeter, Tissue Saturation
|
510(k) Number |
K090807 |
Device Name |
REGIONAL OXIMETER SYSTEM, MODEL 7600 |
Applicant |
NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH |
PLYMOUTH,
MN
55441 -5443
|
|
Applicant Contact |
LORI M ROTH |
Correspondent |
NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH |
PLYMOUTH,
MN
55441 -5443
|
|
Correspondent Contact |
LORI M ROTH |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/25/2009 |
Decision Date | 06/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|