| Device Classification Name |
analyzer, body composition
|
|---|
| 510(K) Number |
K122388 |
|---|
| Model |
514
|
| Device Name |
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 |
|---|
| Applicant |
| SECA GMBH & CO. KG |
| 1300 i street, nw, 11th floor east |
|
washington,
DC
20005 3314
|
|
| Contact |
seth a mailhot |
| Regulation Number | 870.2770
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/06/2012 |
|---|
| Decision Date | 05/02/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
