Device Classification Name |
oximeter
|
510(k) Number |
K860051 |
Device Name |
MODEL 8604 OXYGEN/PULSE MONITOR |
Applicant |
NONIN MEDICAL, INC. |
415 BIRCHWOOD AVE. |
WHITE BEAR LAKE,
MN
55110
|
|
Applicant Contact |
NEAL F NORDLING |
Correspondent |
NONIN MEDICAL, INC. |
415 BIRCHWOOD AVE. |
WHITE BEAR LAKE,
MN
55110
|
|
Correspondent Contact |
NEAL F NORDLING |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/06/1986 |
Decision Date | 06/05/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|