IntelliVue Measurement Rack 6000 (867317)— 510(k) K253654

Substantially Equivalent

Philips Medizin Systeme Böblingen GmbH

FDA 510(k) clearance K253654 for IntelliVue Measurement Rack 6000 (867317), Substantially Equivalent on 2026-03-30. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.

Summary

Philips Medizin Systeme Böblingen's IntelliVue Measurement Rack 6000 (867317) is filed under MSX, physiological monitor network and communication systems. The record doesn't describe the rack beyond its name and that code name.

Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Philips filed from Boeblingen, Germany. Review took 130 calendar days (November 20, 2025 to March 30, 2026).

Clearance details

Applicant
Philips Medizin Systeme Böblingen GmbH
Product code
Product code MSX
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boeblingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MSX

product code MSX
Death
59
Total
59

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.