FDA 510(k)

1Derful HS, 1Derful HT

K-Number: K210884 · 2021-07-27

Decision Date2021-07-27

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

1Derful HS, 1Derful HT is the device name listed in this FDA 510(k) record. The listed applicant is 1derful, Inc.. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210884. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1Derful HS, 1Derful HT?

1Derful HS, 1Derful HT is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is 1derful, Inc.. The 510(k) number is K210884.

When did 1Derful HS, 1Derful HT receive FDA 510(k) clearance?

1Derful HS, 1Derful HT received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210884.

Who is the listed applicant for 1Derful HS, 1Derful HT?

The FDA 510(k) record lists 1derful, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1Derful HS, 1Derful HT?

The FDA product code for 1Derful HS, 1Derful HT is EIH.

Related Devices (Code: EIH)

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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.