Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K031487 |
Device Name |
MODEL AVANT 2120 PULSE OXIMETER AND NIBP |
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 | 870.1130
|
Classification Product Code |
|
Date Received | 05/12/2003 |
Decision Date | 03/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|