| Device Classification Name |
Plethysmograph, Air Displacement For Body Composition Analysis
|
| 510(k) Number |
K924972 |
| Device Name |
SONAMET BODY COMPOSITION ANALYZER |
| Applicant |
| Life Measurement Instruments, Inc. |
| P.O. Box 4456 |
|
Davis,
CA
95617
|
|
| Applicant Contact |
SUSAN AITKENS |
| Correspondent |
| Life Measurement Instruments, Inc. |
| P.O. Box 4456 |
|
Davis,
CA
95617
|
|
| Correspondent Contact |
SUSAN AITKENS |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 09/30/1992 |
| Decision Date | 02/13/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|