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FDA 510(k)

BELRAY II

K-Number: K093240 · 2010-03-22

ApplicantTakara Belmont Corp.
Decision Date2010-03-22
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELRAY II is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont Corp.. It received FDA 510(k) clearance on 2010-03-22 under 510(k) number K093240. 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 BELRAY II?

BELRAY II is a medical device that received FDA 510(k) clearance on 2010-03-22. The listed applicant is Takara Belmont Corp.. The 510(k) number is K093240.

When did BELRAY II receive FDA 510(k) clearance?

BELRAY II received FDA 510(k) clearance on 2010-03-22, under 510(k) number K093240.

Who is the listed applicant for BELRAY II?

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

What is the FDA product code for BELRAY II?

The FDA product code for BELRAY II is EHD.

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Other records listing Takara Belmont Corp. 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.

K101181BEL-CATK072574ALPHARD CONE BEAM CT, MODEL X178

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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