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FDA 510(k)

GE OEC FLUOROSTAR

K-Number: K043076 · 2004-12-22

ApplicantGe Oec Medical Systems, Inc.
Decision Date2004-12-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE OEC FLUOROSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K043076. 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 GE OEC FLUOROSTAR?

GE OEC FLUOROSTAR is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K043076.

When did GE OEC FLUOROSTAR receive FDA 510(k) clearance?

GE OEC FLUOROSTAR received FDA 510(k) clearance on 2004-12-22, under 510(k) number K043076.

Who is the listed applicant for GE OEC FLUOROSTAR?

The FDA 510(k) record lists Ge Oec Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE OEC FLUOROSTAR?

The FDA product code for GE OEC FLUOROSTAR is OWB.

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Other records listing Ge Oec Medical Systems, Inc. as applicant

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.

K233669OEC 3DK203346OEC 3DK192819OEC EliteK172550OEC EliteK171565OEC EliteK111551OEC(R) 9800, OEC(R) 9800 PLUS

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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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