Device Classification Name |
Oximeter
|
510(k) Number |
K893221 |
Device Name |
MODEL 8500 HAND HELD PULSE OXIMETER |
Applicant |
NONIN MEDICAL, INC. |
12900 HIGHWAY 55 |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
NEAL F NORDLING |
Correspondent |
NONIN MEDICAL, INC. |
12900 HIGHWAY 55 |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
NEAL F NORDLING |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/27/1989 |
Decision Date | 02/28/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|