Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K171801 |
Device Name |
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable |
Applicant |
Philips Medizin Systeme Boeblingen GmbH |
Hewlett-Packard-Str.-2 |
Boeblingen,
DE
71034
|
|
Applicant Contact |
Markus Stacha |
Correspondent |
Philips Medizin Systeme Boeblingen GmbH |
Hewlett-Packard-Str.-2 |
Boeblingen,
DE
71034
|
|
Correspondent Contact |
Markus Stacha |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/16/2017 |
Decision Date | 10/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|