System 83 Plus Washer/Disinfector
K-Number: K173590 · 2020-03-30
ApplicantCustom Ultrasonics, Inc.
Decision Date2020-03-30
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
System 83 Plus Washer/Disinfector is a medical device manufactured by Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2020-03-30 under approval number K173590. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the System 83 Plus Washer/Disinfector?
System 83 Plus Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2020-03-30. It is manufactured by Custom Ultrasonics, Inc.. The 510(k) number is K173590.
When was System 83 Plus Washer/Disinfector approved by the FDA?
System 83 Plus Washer/Disinfector received FDA 510(k) clearance on 2020-03-30, under approval number K173590.
What company makes System 83 Plus Washer/Disinfector?
System 83 Plus Washer/Disinfector is manufactured by Custom Ultrasonics, Inc..
What is the FDA product code for System 83 Plus Washer/Disinfector?
The FDA product code for System 83 Plus Washer/Disinfector is FEB.
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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.