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FDA 510(k)

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

K-Number: K040748 · 2004-06-02

ApplicantTakara Belmont USA, Inc.
Decision Date2004-06-02
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K040748. 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 ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM?

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K040748.

When did ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM receive FDA 510(k) clearance?

ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM received FDA 510(k) clearance on 2004-06-02, under 510(k) number K040748.

Who is the listed applicant for ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM?

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

What is the FDA product code for ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM?

The FDA product code for ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM 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 Takara Belmont USA, 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.

K102456INTRAORAL BELSENSOR GOLDK072273BELMONT QUOLIS 5000 SERIES DENTAL UNITK062529BELMAX CM MODEL X168K041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CMK042260PHOT-X II, MODEL 303

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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