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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics, Inc.. It received FDA 510(k) clearance on 2020-03-30 under 510(k) 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. The listed applicant is Custom Ultrasonics, Inc.. The 510(k) number is K173590.

When did System 83 Plus Washer/Disinfector receive FDA 510(k) clearance?

System 83 Plus Washer/Disinfector received FDA 510(k) clearance on 2020-03-30, under 510(k) number K173590.

Who is the listed applicant for System 83 Plus Washer/Disinfector?

The FDA 510(k) record lists Custom Ultrasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for System 83 Plus Washer/Disinfector?

The FDA product code for System 83 Plus Washer/Disinfector is FEB.

Other records listing Custom Ultrasonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162120Scope-Assist Flushing Sink

Related Devices (Code: FEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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