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FDA 510(k)

COFFMAN TOMOGRAPH

K-Number: K913652 · 1991-10-30

ApplicantCoffman Dental
Decision Date1991-10-30
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COFFMAN TOMOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Coffman Dental. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K913652. 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 COFFMAN TOMOGRAPH?

COFFMAN TOMOGRAPH is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Coffman Dental. The 510(k) number is K913652.

When did COFFMAN TOMOGRAPH receive FDA 510(k) clearance?

COFFMAN TOMOGRAPH received FDA 510(k) clearance on 1991-10-30, under 510(k) number K913652.

Who is the listed applicant for COFFMAN TOMOGRAPH?

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

What is the FDA product code for COFFMAN TOMOGRAPH?

The FDA product code for COFFMAN TOMOGRAPH 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 Coffman Dental 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.

K924130COFFMAN IMPLANT TOMOGRAPH

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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