Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K030316 |
Device Name |
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) |
Applicant |
INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. |
SUITE C |
newberg,
OR
97132
|
|
Applicant Contact |
kendra rathkey |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
camas,
WA
98607 -9526
|
|
Correspondent Contact |
john so |
Regulation Number | 870.2360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/30/2003 |
Decision Date | 08/07/2003 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|