Device Classification Name |
analyzer, body composition
|
510(k) Number |
K031582 |
Device Name |
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 |
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 | 870.2770
|
Classification Product Code |
|
Date Received | 05/21/2003 |
Decision Date | 08/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|