Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVOTECH ECR

K-Number: K152189 · 2016-07-20

ApplicantAdvanced Sterilization Products (Asp)
Decision Date2016-07-20
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVOTECH ECR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152189. 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 ECR?

EVOTECH ECR is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K152189.

When did EVOTECH ECR receive FDA 510(k) clearance?

EVOTECH ECR received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152189.

Who is the listed applicant for EVOTECH ECR?

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

What is the FDA product code for EVOTECH ECR?

The FDA product code for EVOTECH ECR is FEB.

Other records listing Advanced Sterilization Products (Asp) 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.

K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderK181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorK182404STERRAD VELOCITY Biological IndicatorK170039STERRAD VELOCITY Biological Indictator and Reader

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.

↑