Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K151781 |
Device Name |
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor |
Applicant |
IVY BIOMEDICAL SYSTEMS INC. |
11 BUSINESS PARK DRIVE |
BRANFORD,
CT
06405
|
|
Applicant Contact |
DICK LISTRO |
Correspondent |
IVY BIOMEDICAL SYSTEMS INC. |
11 BUSINESS PARK DRIVE |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
DICK LISTRO |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 07/01/2015 |
Decision Date | 05/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|