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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 a medical device manufactured by Digimed Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval 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. It is manufactured by Digimed Co., Ltd.. The 510(k) number is K220574.

When was HYBRID S70 approved by the FDA?

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

What company makes HYBRID S70?

HYBRID S70 is manufactured by Digimed Co., Ltd..

What is the FDA product code for HYBRID S70?

The FDA product code for HYBRID S70 is EHD.

Other Devices by Digimed Co., Ltd.

K181891Portable X-ray System (Model: MiniX-V, Mini X-S) K220579Hybrid C70 K221587DHX-70H, XTG-70H

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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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