Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K042904 |
Device Name |
INFINITY KAPPA XLT |
Applicant |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
PENELOPE H GRECO |
Correspondent |
Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
PENELOPE H GRECO |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 10/21/2004 |
Decision Date | 02/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|