Device Classification Name |
analyzer, body composition
|
510(k) Number |
K081587 |
Device Name |
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 |
Applicant |
KRELL PRECISION (YANG ZHOU) CO., LTD. |
340 SHADY GROVE RD. |
FLINTVILLE,
TN
37335 -5031
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
KRELL PRECISION (YANG ZHOU) CO., LTD. |
340 SHADY GROVE RD. |
FLINTVILLE,
TN
37335 -5031
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 06/05/2008 |
Decision Date | 10/24/2008 |
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
|
|
|