Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K170181 |
Device Name |
Prizma |
Applicant |
G-Medical Innovations Ltd. |
5 Openheimer St., Park Rabin |
rehovot,
IL
7670105
|
|
Applicant Contact |
n. epstein |
Correspondent |
Hogan Lovells US LLP |
Columbia Square, 555 Thirteenth Street, NW |
washington,
DC
20004
|
|
Correspondent Contact |
jonathan kahan |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/19/2017 |
Decision Date | 09/01/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|