Device Classification Name |
Electrocardiograph
|
510(k) Number |
K854840 |
Device Name |
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A |
Applicant |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
RICHARD A MENTELOS |
Correspondent |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
RICHARD A MENTELOS |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 12/04/1985 |
Decision Date | 05/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|