Device Classification Name |
Electrocardiograph
|
510(k) Number |
K043380 |
Device Name |
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 |
Applicant |
MONEBO TECHNOLOGIES, INC. |
1800 BARTON CREEK BLVD |
AUSTIN,
TX
78735
|
|
Applicant Contact |
DALE J MISCZYNSKI |
Correspondent |
MONEBO TECHNOLOGIES, INC. |
1800 BARTON CREEK BLVD |
AUSTIN,
TX
78735
|
|
Correspondent Contact |
DALE J MISCZYNSKI |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/08/2004 |
Decision Date | 04/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|