Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K063087 |
Device Name |
MODIFICATION TO MODEL 750 SERIES MONITOR |
Applicant |
CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. |
BRANFORD,
CT
06405
|
|
Applicant Contact |
RON JEFFREY |
Correspondent |
CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. |
BRANFORD,
CT
06405
|
|
Correspondent Contact |
RON JEFFREY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 10/10/2006 |
Decision Date | 12/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|