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FDA 510(k)

Hexa-Temp

K-Number: K214071 · 2022-03-10

ApplicantSpident Co., Ltd.
Decision Date2022-03-10
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Hexa-Temp 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 2022-03-10 under 510(k) number K214071. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hexa-Temp?

Hexa-Temp is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Spident Co., Ltd.. The 510(k) number is K214071.

When did Hexa-Temp receive FDA 510(k) clearance?

Hexa-Temp received FDA 510(k) clearance on 2022-03-10, under 510(k) number K214071.

Who is the listed applicant for Hexa-Temp?

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 Hexa-Temp?

The FDA product code for Hexa-Temp is EBG.

Other records listing Spident Co., Ltd. as applicant

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Related Devices (Code: EBG)

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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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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