FDA 510(k) Premarket Notification K230604: IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

Submission Details & Decision

Normalized public record details for 510(k) notification K230604.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K230604

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

Product Code

MHX

Decision Date

2023-11-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2023-03-03

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