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
|
|
|