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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 a medical device manufactured by Micron Corporation. It received FDA 510(k) clearance on 2018-03-08 under approval 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. It is manufactured by Micron Corporation. The 510(k) number is K171150.

When was AW-100 approved by the FDA?

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

What company makes AW-100?

AW-100 is manufactured by Micron Corporation.

What is the FDA product code for AW-100?

The FDA product code for AW-100 is ELC.

Other Devices by Micron Corporation

Related Devices (Code: ELC)

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.