BiWaze Clear System
K-Number: K231728 · 2024-04-08
ApplicantAbmrc, LLC
Decision Date2024-04-08
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 2024-04-08 under approval number K231728. 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 2024-04-08. It is manufactured by Abmrc, LLC. The 510(k) number is K231728.
When was BiWaze Clear System approved by the FDA?
BiWaze Clear System received FDA 510(k) clearance on 2024-04-08, under approval number K231728.
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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