Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K041816 |
Device Name |
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY |
Applicant |
RTX HEALTHCARE A/S |
STROEMMEN 6 |
NOERRESUNDBY,
DK
DK-9400
|
|
Applicant Contact |
NIELS OLE ANDERSEN |
Correspondent |
KEMA QUALITY B.V. |
4377 COUNTY LINE ROAD |
CHALFONT,
PA
18914
|
|
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 07/06/2004 |
Decision Date | 07/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|