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FDA 510(k)

Philips Hemodynamic Application R1.0

K-Number: K181311 · 2018-09-07

ApplicantPhilips Medical Systems Nederlands B.V.
Decision Date2018-09-07
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips Hemodynamic Application R1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181311. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips Hemodynamic Application R1.0?

Philips Hemodynamic Application R1.0 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K181311.

When did Philips Hemodynamic Application R1.0 receive FDA 510(k) clearance?

Philips Hemodynamic Application R1.0 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181311.

Who is the listed applicant for Philips Hemodynamic Application R1.0?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Hemodynamic Application R1.0?

The FDA product code for Philips Hemodynamic Application R1.0 is MWI.

Other records listing Philips Medical Systems Nederlands B.V. as applicant

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Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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