Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K981733 |
Device Name |
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 |
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 | 05/18/1998 |
Decision Date | 02/04/1999 |
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
|
Recalls |
CDRH Recalls
|
|
|