Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K133703 |
Device Name |
PHYSIOGLOVE ET SYSTEM |
Applicant |
COMMWELL R&D LTD. |
555 THIRTEENTH STREET NW |
washington,
DC
20004
|
|
Applicant Contact |
jonathon kahan |
Correspondent |
COMMWELL R&D LTD. |
555 THIRTEENTH STREET NW |
washington,
DC
20004
|
|
Correspondent Contact |
jonathon kahan |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/03/2013 |
Decision Date | 08/18/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|