Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K913997 |
Device Name |
SAECG CARDIOGRAPH MODEL M1754A |
Applicant |
HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. |
MCMINNVILLE,
OR
97128
|
|
Applicant Contact |
MONICA FERRANTE |
Correspondent |
HEWLETT-PACKARD CO. |
1700 SOUTH BAKER ST. |
MCMINNVILLE,
OR
97128
|
|
Correspondent Contact |
MONICA FERRANTE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/06/1991 |
Decision Date | 03/06/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|