Device Classification Name |
oximeter
|
510(k) Number |
K001085 |
Device Name |
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 |
Applicant |
NONIN MEDICAL, INC. |
2605 FERNBROOK LANE, NORTH |
MINNEAPOLIS,
MN
55447 -4755
|
|
Applicant Contact |
RICHARD P BENNETT |
Correspondent |
NONIN MEDICAL, INC. |
2605 FERNBROOK LANE, NORTH |
MINNEAPOLIS,
MN
55447 -4755
|
|
Correspondent Contact |
RICHARD P BENNETT |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 04/04/2000 |
Decision Date | 05/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|