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FDA 510(k)

2D PERFUSION

K-Number: K132147 · 2013-12-16

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2013-12-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2D PERFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K132147. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2D PERFUSION?

2D PERFUSION is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K132147.

When did 2D PERFUSION receive FDA 510(k) clearance?

2D PERFUSION received FDA 510(k) clearance on 2013-12-16, under 510(k) number K132147.

Who is the listed applicant for 2D PERFUSION?

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

What is the FDA product code for 2D PERFUSION?

The FDA product code for 2D PERFUSION is OWB.

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

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Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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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