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FDA 510(k)

REXTAR X

K-Number: K132041 · 2013-07-31

ApplicantMeta Biomed, Inc.
Decision Date2013-07-31
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REXTAR X 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 2013-07-31 under 510(k) number K132041. 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 X?

REXTAR X is a medical device that received FDA 510(k) clearance on 2013-07-31. The listed applicant is Meta Biomed, Inc.. The 510(k) number is K132041.

When did REXTAR X receive FDA 510(k) clearance?

REXTAR X received FDA 510(k) clearance on 2013-07-31, under 510(k) number K132041.

Who is the listed applicant for REXTAR X?

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 X?

The FDA product code for REXTAR X 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.

K122016REXTAR, REXTAR LCD

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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