FDA 510(k)

AUTOLIGN

K-Number: K192847 · 2020-07-21

Decision Date2020-07-21

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AUTOLIGN is the device name listed in this FDA 510(k) record. The listed applicant is Diorco Co., Ltd.. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K192847. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOLIGN?

AUTOLIGN is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Diorco Co., Ltd.. The 510(k) number is K192847.

When did AUTOLIGN receive FDA 510(k) clearance?

AUTOLIGN received FDA 510(k) clearance on 2020-07-21, under 510(k) number K192847.

Who is the listed applicant for AUTOLIGN?

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

What is the FDA product code for AUTOLIGN?

The FDA product code for AUTOLIGN is PNN.

Related Devices (Code: PNN)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.