Device Classification Name |
Oximeter
|
510(k) Number |
K053130 |
Device Name |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
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 | 11/08/2005 |
Decision Date | 01/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|