Device Classification Name |
electrocardiograph
|
510(k) Number |
K031182 |
Device Name |
ELI 200+ AUDICOR |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
HARLAN L VAN MATRE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
CHANTEL CARSON |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/15/2003 |
Decision Date | 07/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|