EVOTECH ECR
K-Number: K152189 · 2016-07-20
Decision Date2016-07-20
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
EVOTECH ECR is a medical device manufactured by Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2016-07-20 under approval 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. It is manufactured by Advanced Sterilization Products (Asp). The 510(k) number is K152189.
When was EVOTECH ECR approved by the FDA?
EVOTECH ECR received FDA 510(k) clearance on 2016-07-20, under approval number K152189.
What company makes EVOTECH ECR?
EVOTECH ECR is manufactured by Advanced Sterilization Products (Asp).
What is the FDA product code for EVOTECH ECR?
The FDA product code for EVOTECH ECR is FEB.
Other Devices by Advanced Sterilization Products (Asp)
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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.