Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K181248 |
Device Name |
Comarch e-Care Platform |
Applicant |
Comarch Healthcare SA |
al. Jana Pawla II 39a, |
Krakow,
PL
31-864
|
|
Applicant Contact |
Irmina Serafin |
Correspondent |
mdi Consultants, Inc. |
55 Northern Blvd, Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Jigar Shah |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 05/10/2018 |
Decision Date | 10/22/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|