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FDA 510(k)

HYBRID S70

K-Number: K220574 · 2022-04-22

ApplicantDigimed Co., Ltd.
Decision Date2022-04-22
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYBRID S70 is the device name listed in this FDA 510(k) record. The listed applicant is Digimed Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K220574. 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 HYBRID S70?

HYBRID S70 is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Digimed Co., Ltd.. The 510(k) number is K220574.

When did HYBRID S70 receive FDA 510(k) clearance?

HYBRID S70 received FDA 510(k) clearance on 2022-04-22, under 510(k) number K220574.

Who is the listed applicant for HYBRID S70?

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

What is the FDA product code for HYBRID S70?

The FDA product code for HYBRID S70 is EHD.

Other records listing Digimed Co., Ltd. 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.

K221587DHX-70H, XTG-70HK220579Hybrid C70K181891Portable X-ray System (Model: MiniX-V, Mini X-S)

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.

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.K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker 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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