Device Classification Name |
Electrocardiograph
|
510(k) Number |
K142105 |
Device Name |
ELI 380 ELECTROCARDIOGRAPH |
Applicant |
MORTARA INSTRUMENT, INC |
7865 NORTH 86TH STREET |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
AMY YANG |
Correspondent |
MORTARA INSTRUMENT, INC |
7865 NORTH 86TH STREET |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
AMY YANG |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 08/01/2014 |
Decision Date | 09/05/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|