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FDA 510(k)

REXTAR, REXTAR LCD

K-Number: K122016 · 2013-03-01

ApplicantMeta Biomed, Inc.
Decision Date2013-03-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REXTAR, REXTAR LCD is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed, Inc.. It received FDA 510(k) clearance on 2013-03-01 under 510(k) number K122016. 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 REXTAR, REXTAR LCD?

REXTAR, REXTAR LCD is a medical device that received FDA 510(k) clearance on 2013-03-01. The listed applicant is Meta Biomed, Inc.. The 510(k) number is K122016.

When did REXTAR, REXTAR LCD receive FDA 510(k) clearance?

REXTAR, REXTAR LCD received FDA 510(k) clearance on 2013-03-01, under 510(k) number K122016.

Who is the listed applicant for REXTAR, REXTAR LCD?

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

What is the FDA product code for REXTAR, REXTAR LCD?

The FDA product code for REXTAR, REXTAR LCD is EHD.

Related Clinical Trials

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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Other records listing Meta Biomed, 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.

K132041REXTAR X

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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