Device Classification Name |
Stethoscope, Electronic
|
510(k) Number |
K103516 |
Device Name |
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 |
Applicant |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
BEAVERTON,
OR
97008 -7196
|
|
Applicant Contact |
EARL ANDERSON |
Correspondent |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE |
SUITE D |
BEAVERTON,
OR
97008 -7196
|
|
Correspondent Contact |
EARL ANDERSON |
Regulation Number | 870.1875
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/30/2010 |
Decision Date | 02/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|