Device Classification Name |
Electrocardiograph
|
510(k) Number |
K102206 |
Device Name |
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
CHARLES MORREALE |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
CHARLES MORREALE |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 08/05/2010 |
Decision Date | 02/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|