FDA 510(k) Premarket Notification K182979: IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3

Submission Details & Decision

Normalized public record details for 510(k) notification K182979.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K182979

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3

Product Code

MHX

Decision Date

2019-11-19

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Special

Third Party Flag

Date Received

2018-10-26

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