Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K113493 |
Device Name |
TCX-I REMOTE CARE MANAGEMENT SYSTEM |
Applicant |
BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 |
FOXBORO,
MA
02035
|
|
Applicant Contact |
MICHEAL MATHUR |
Correspondent |
BL HEALTHCARE, INC. |
33 COMMERCIAL ST., SUITE #3 |
FOXBORO,
MA
02035
|
|
Correspondent Contact |
MICHEAL MATHUR |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/25/2011 |
Decision Date | 12/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|