FDA 510(k) Premarket Notification K223574: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

Submission Details & Decision

Normalized public record details for 510(k) notification K223574.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K223574

Applicant / Sponsor

Philips Medizin Systeme Boeblingen GmbH

Device Name

IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

Product Code

MHX

Decision Date

2023-08-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2022-11-30

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.