Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K992713 |
Device Name |
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 |
Applicant |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN |
SKOVLUNDE,
DK
DK-2740
|
|
Applicant Contact |
ANN-CHRISTINE JONSSON |
Correspondent |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN |
SKOVLUNDE,
DK
DK-2740
|
|
Correspondent Contact |
ANN-CHRISTINE JONSSON |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 08/12/1999 |
Decision Date | 11/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|