BiWaze Clear System
K-Number: K213564 · 2022-12-21
ApplicantAbmrc, LLC
Decision Date2022-12-21
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
BiWaze Clear System is a medical device manufactured by Abmrc, LLC. It received FDA 510(k) clearance on 2022-12-21 under approval number K213564. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BiWaze Clear System?
BiWaze Clear System is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Abmrc, LLC. The 510(k) number is K213564.
When was BiWaze Clear System approved by the FDA?
BiWaze Clear System received FDA 510(k) clearance on 2022-12-21, under approval number K213564.
What company makes BiWaze Clear System?
BiWaze Clear System is manufactured by Abmrc, LLC.
What is the FDA product code for BiWaze Clear System?
The FDA product code for BiWaze Clear System is NHJ.
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Official Source
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