Device Classification Name |
Electrocardiograph
|
510(k) Number |
K090249 |
Device Name |
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM |
Applicant |
HARBINGER MEDICAL, INC. |
10125 CROSSTOWN CIRCLE |
SUITE 105 |
EDEN PRAIRIE,
MN
55344 -3316
|
|
Applicant Contact |
HAROLD HOIUM |
Correspondent |
HARBINGER MEDICAL, INC. |
10125 CROSSTOWN CIRCLE |
SUITE 105 |
EDEN PRAIRIE,
MN
55344 -3316
|
|
Correspondent Contact |
HAROLD HOIUM |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 02/02/2009 |
Decision Date | 04/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|