Device Classification Name |
electrocardiograph
|
510(k) Number |
K070539 |
Device Name |
MORTARA ELI 10 ELECTROCARDIOGRAPH |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
LAURA M SPIEGELHOFF |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
LAURA M SPIEGELHOFF |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 02/26/2007 |
Decision Date | 03/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|