Device Classification Name |
analyzer, body composition
|
510(k) Number |
K971554 |
Device Name |
BODYSTAT |
Applicant |
BODYSTAT LTD. |
PO BOX 50 |
DOUGLAS ISLE OF MAN |
BRITISH ISLES,
BR
IM99 1DQ
|
|
Applicant Contact |
L.J. MEEUWSEN |
Correspondent |
BODYSTAT LTD. |
PO BOX 50 |
DOUGLAS ISLE OF MAN |
BRITISH ISLES,
BR
IM99 1DQ
|
|
Correspondent Contact |
L.J. MEEUWSEN |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 04/30/1997 |
Decision Date | 11/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|