Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K141792 |
Device Name |
GENESIS TOUCH SYSTEM |
Applicant |
HONEYWELL HOMMED |
3400 INTERTECH DRIVE |
BROOKFIELD,
WI
53045
|
|
Applicant Contact |
CLAUDIA JACKSON |
Correspondent |
HONEYWELL HOMMED |
3400 INTERTECH DRIVE |
BROOKFIELD,
WI
53045
|
|
Correspondent Contact |
CLAUDIA JACKSON |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 07/02/2014 |
Decision Date | 11/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|