FDA 510(k)

ADH19

K-Number: K192961 · 2019-10-31

Decision Date2019-10-31

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ADH19 is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2019-10-31 under 510(k) number K192961. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADH19?

ADH19 is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K192961.

When did ADH19 receive FDA 510(k) clearance?

ADH19 received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192961.

Who is the listed applicant for ADH19?

The FDA 510(k) record lists 3M Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADH19?

The FDA product code for ADH19 is KLE.

Other records listing 3M Deutschland GmbH as applicant

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Related Devices (Code: KLE)

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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.