FDA 510(k) Premarket Notification K171801: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

Submission Details & Decision

Normalized public record details for 510(k) notification K171801.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K171801

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

Product Code

MHX

Decision Date

2017-10-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2017-06-16

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