FDA 510(k)

EZ-BLOCKER

K-Number: K121462 · 2012-09-28

Decision Date2012-09-28

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EZ-BLOCKER is the device name listed in this FDA 510(k) record. The listed applicant is Ez-Blocker B.V.. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K121462. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-BLOCKER?

EZ-BLOCKER is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Ez-Blocker B.V.. The 510(k) number is K121462.

When did EZ-BLOCKER receive FDA 510(k) clearance?

EZ-BLOCKER received FDA 510(k) clearance on 2012-09-28, under 510(k) number K121462.

Who is the listed applicant for EZ-BLOCKER?

The FDA 510(k) record lists Ez-Blocker B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-BLOCKER?

The FDA product code for EZ-BLOCKER is CBI.

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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.