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FDA 510(k)

AW-100

K-Number: K171150 · 2018-03-08

Decision Date2018-03-08
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AW-100 is the device name listed in this FDA 510(k) record. The listed applicant is Micron Corporation. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K171150. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AW-100?

AW-100 is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Micron Corporation. The 510(k) number is K171150.

When did AW-100 receive FDA 510(k) clearance?

AW-100 received FDA 510(k) clearance on 2018-03-08, under 510(k) number K171150.

Who is the listed applicant for AW-100?

The FDA 510(k) record lists Micron Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AW-100?

The FDA product code for AW-100 is ELC.

Other records listing Micron Corporation as applicant

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.

Related Devices (Code: ELC)

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.

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.