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FDA 510(k)

A-dec 300, A-dec 500

K-Number: K213932 · 2022-03-02

ApplicantA-Dec, Inc.
Decision Date2022-03-02
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-dec 300, A-dec 500 is the device name listed in this FDA 510(k) record. The listed applicant is A-Dec, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213932. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-dec 300, A-dec 500?

A-dec 300, A-dec 500 is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is A-Dec, Inc.. The 510(k) number is K213932.

When did A-dec 300, A-dec 500 receive FDA 510(k) clearance?

A-dec 300, A-dec 500 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213932.

Who is the listed applicant for A-dec 300, A-dec 500?

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

What is the FDA product code for A-dec 300, A-dec 500?

The FDA product code for A-dec 300, A-dec 500 is EIA.

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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.

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