Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K884096 |
Device Name |
PATIENT MONITOR MODEL 701 |
Applicant |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
BRENDA E LUNDY |
Correspondent |
IVY BIOMEDICAL SYSTEMS, INC. |
11 BUSINESS PARK DR. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
BRENDA E LUNDY |
Regulation Number | 870.2300 |
Classification Product Code |
|
Date Received | 09/28/1988 |
Decision Date | 02/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|