Device Classification Name |
Electrocardiograph
|
510(k) Number |
K904606 |
Device Name |
MODEL 405 |
Applicant |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
M SIMON |
Correspondent |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
M SIMON |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 10/10/1990 |
Decision Date | 03/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|