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FDA 510(k)

VISTEO

K-Number: K093105 · 2010-10-18

ApplicantOwandy
Decision Date2010-10-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISTEO is the device name listed in this FDA 510(k) record. The listed applicant is Owandy. It received FDA 510(k) clearance on 2010-10-18 under 510(k) number K093105. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTEO?

VISTEO is a medical device that received FDA 510(k) clearance on 2010-10-18. The listed applicant is Owandy. The 510(k) number is K093105.

When did VISTEO receive FDA 510(k) clearance?

VISTEO received FDA 510(k) clearance on 2010-10-18, under 510(k) number K093105.

Who is the listed applicant for VISTEO?

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

What is the FDA product code for VISTEO?

The FDA product code for VISTEO is EHD.

Related Clinical Trials

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Other records listing Owandy 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.

K130443I-MAX TOUCH 3DK083057I-MAX TOUCHK070505KRYSTAL-X WIFIK062403IMAX CEPH DIGITAL X-RAY SENSOR

Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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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