AW-100
FDA 510(k) K171150 · Micron Corporation
510(k) numberK171150
Submission
- Device name
- AW-100
- Applicant
- Micron Corporation
Ota-Ku, Tokyo, JP - Received
- April 19, 2017
- Decision date
- March 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was AW-100 cleared by the FDA?
AW-100 (K171150) received a 510(k) decision of Substantially Equivalent on March 8, 2018, 323 days after the submission was received.
What is the product code of K171150?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.