| Device Classification Name |
Plethysmograph, Impedance
|
| 510(k) Number |
K862383 |
| Device Name |
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER |
| Applicant |
| Rjl Systems, Inc. |
| 9930 Whittier |
|
Detroit,
MI
48224
|
|
| Applicant Contact |
RUDOLPH J LIEDTKE |
| Correspondent |
| Rjl Systems, Inc. |
| 9930 Whittier |
|
Detroit,
MI
48224
|
|
| Correspondent Contact |
RUDOLPH J LIEDTKE |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 06/24/1986 |
| Decision Date | 02/03/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|