Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K151027 |
Device Name |
zensor system |
Applicant |
INTELESENS LIMITED |
17 HERON ROAD |
BELFAST,
GB
BT3 9LE
|
|
Applicant Contact |
PATRICIA PEPPER |
Correspondent |
PROMEDIC, INC. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134 -2958
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 04/17/2015 |
Decision Date | 10/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|