Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K002028 |
Device Name |
BRAVO PH MONITORING SYSTEM |
Applicant |
ENDONETICS, INC. |
987 UNIVERSITY AVE.;STE. 14 |
LOS GATOS,
CA
95032
|
|
Applicant Contact |
WILLIAM A KNAPE |
Correspondent |
ENDONETICS, INC. |
987 UNIVERSITY AVE.;STE. 14 |
LOS GATOS,
CA
95032
|
|
Correspondent Contact |
WILLIAM A KNAPE |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 07/03/2000 |
Decision Date | 09/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|