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FDA 510(k)

OEC 9900 ELITE

K-Number: K073543 · 2008-05-02

ApplicantGe Oec Medical Systems
Decision Date2008-05-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC 9900 ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K073543. 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 OEC 9900 ELITE?

OEC 9900 ELITE is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Ge Oec Medical Systems. The 510(k) number is K073543.

When did OEC 9900 ELITE receive FDA 510(k) clearance?

OEC 9900 ELITE received FDA 510(k) clearance on 2008-05-02, under 510(k) number K073543.

Who is the listed applicant for OEC 9900 ELITE?

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

What is the FDA product code for OEC 9900 ELITE?

The FDA product code for OEC 9900 ELITE is OWB.

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Other records listing Ge Oec Medical Systems 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.

K0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSK052039GE OEC ALTITUDEK024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMK022069OEC FLUOROTRAK 9800 PLUSK021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMK003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM

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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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