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FDA 510(k)

Core·it Dual

K-Number: K262982 · 2026-09-21

Decision Date2026-09-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Core·it Dual is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K262982. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Core·it Dual?

Core·it Dual is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Spident Co., Ltd.. The 510(k) number is K262982.

When did Core·it Dual receive FDA 510(k) clearance?

Core·it Dual received FDA 510(k) clearance on 2026-09-21, under 510(k) number K262982.

Who is the listed applicant for Core·it Dual?

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

What is the FDA product code for Core·it Dual?

The FDA product code for Core·it Dual is EBF.

Other records listing Spident 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.

View all 13 devices →

Related Devices (Code: EBF)

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.

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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