Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K040309 |
Device Name |
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 |
Applicant |
NIHON SEIMITSU SOKKI CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
NIHON SEIMITSU SOKKI CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/09/2004 |
Decision Date | 02/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|