Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K001670 |
Device Name |
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 |
Applicant |
OMRON HEALTHCARE, INC. |
300 LAKEVIEW PKWY. |
VERNON HILLS,
IL
60061
|
|
Applicant Contact |
OSAMU SHIRASAKI |
Correspondent |
OMRON HEALTHCARE, INC. |
300 LAKEVIEW PKWY. |
VERNON HILLS,
IL
60061
|
|
Correspondent Contact |
OSAMU SHIRASAKI |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 06/01/2000 |
Decision Date | 06/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|