Device Classification Name |
oximeter
|
510(k) Number |
K002690 |
Device Name |
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 |
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 | 08/29/2000 |
Decision Date | 10/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|