Device Classification Name |
electrocardiograph
|
510(k) Number |
K062282 |
Device Name |
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 |
Applicant |
MONEBO TECHNOLOGIES, INC. |
1800 BARTON CREEK BLVD. |
AUSTIN,
TX
78735 -1606
|
|
Applicant Contact |
DALE J MISCZYNSKI |
Correspondent |
MONEBO TECHNOLOGIES, INC. |
1800 BARTON CREEK BLVD. |
AUSTIN,
TX
78735 -1606
|
|
Correspondent Contact |
DALE J MISCZYNSKI |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 08/07/2006 |
Decision Date | 03/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|