FDA 510(k)

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

K-Number: K061899 · 2006-10-26

ApplicantAdvanced Sterilization Products

Decision Date2006-10-26

Product CodeFEB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2006-10-26 under 510(k) number K061899. 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 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM?

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-26. The listed applicant is Advanced Sterilization Products. The 510(k) number is K061899.

When did EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM receive FDA 510(k) clearance?

EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM received FDA 510(k) clearance on 2006-10-26, under 510(k) number K061899.

Who is the listed applicant for EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM?

The FDA 510(k) record lists Advanced Sterilization Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM?

The FDA product code for EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM 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.