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FDA 510(k)

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

K-Number: K000061 · 2000-04-07

ApplicantMinxray, Inc.
Decision Date2000-04-07
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2000-04-07 under 510(k) number K000061. 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 MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT?

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 2000-04-07. The listed applicant is Minxray, Inc.. The 510(k) number is K000061.

When did MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT receive FDA 510(k) clearance?

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT received FDA 510(k) clearance on 2000-04-07, under 510(k) number K000061.

Who is the listed applicant for MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT?

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

What is the FDA product code for MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT?

The FDA product code for MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT is EHD.

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Other records listing Minxray, Inc. as applicant

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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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