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FDA 510(k)

MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING

K-Number: K063876 · 2007-06-14

ApplicantMedivators Reprocessing Systems
Decision Date2007-06-14
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING is the device name listed in this FDA 510(k) record. The listed applicant is Medivators Reprocessing Systems. It received FDA 510(k) clearance on 2007-06-14 under 510(k) number K063876. 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 MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING?

MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING is a medical device that received FDA 510(k) clearance on 2007-06-14. The listed applicant is Medivators Reprocessing Systems. The 510(k) number is K063876.

When did MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING receive FDA 510(k) clearance?

MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING received FDA 510(k) clearance on 2007-06-14, under 510(k) number K063876.

Who is the listed applicant for MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING?

The FDA 510(k) record lists Medivators Reprocessing Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING?

The FDA product code for MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING is FEB.

Related Clinical Trials

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.

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Other records listing Medivators Reprocessing Systems 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.

K102996MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSORK082988MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT

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.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.

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.

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