Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K152407 |
Device Name |
Infinity Delta, Infinity Delta XL, Infinity Kappa |
Applicant |
Draeger Medical Sytems, Inc. |
6 Tech Drive |
Andover,
MA
01810
|
|
Applicant Contact |
Beth Zis |
Correspondent |
Draeger Medical Sytems, Inc. |
6 Tech Drive |
Andover,
MA
01810
|
|
Correspondent Contact |
Beth Zis |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 08/25/2015 |
Decision Date | 09/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|