Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K180017 |
Device Name |
MX40 Release C.01 |
Applicant |
Philips Medical Systems |
3000 Minuteman Road |
Andover,
MA
01810
|
|
Applicant Contact |
Theresa Poole |
Correspondent |
Philips Medical Systems |
3000 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Theresa Poole |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/02/2018 |
Decision Date | 07/24/2018 |
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
|
|
|