| Device Classification Name |
Plethysmograph, Impedance
|
| 510(k) Number |
K881841 |
| Device Name |
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS |
| Applicant |
| BUCKMAN CO., INC. |
| 921 CALLE VERDE |
|
MARTINEZ,
CA
94553
|
|
| Applicant Contact |
DAVID W SCHLERF |
| Correspondent |
| BUCKMAN CO., INC. |
| 921 CALLE VERDE |
|
MARTINEZ,
CA
94553
|
|
| Correspondent Contact |
DAVID W SCHLERF |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 05/02/1988 |
| Decision Date | 12/13/1988 |
| 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
|
|
|