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FDA 510(k)

ANOVA CONTAINMENT DEVICE

K-Number: K063461 · 2009-08-13

ApplicantAnova Corporation
Decision Date2009-08-13
Product CodeEZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANOVA CONTAINMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Anova Corporation. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K063461. The device is classified under product code EZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANOVA CONTAINMENT DEVICE?

ANOVA CONTAINMENT DEVICE is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Anova Corporation. The 510(k) number is K063461.

When did ANOVA CONTAINMENT DEVICE receive FDA 510(k) clearance?

ANOVA CONTAINMENT DEVICE received FDA 510(k) clearance on 2009-08-13, under 510(k) number K063461.

Who is the listed applicant for ANOVA CONTAINMENT DEVICE?

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

What is the FDA product code for ANOVA CONTAINMENT DEVICE?

The FDA product code for ANOVA CONTAINMENT DEVICE is EZX.

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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.

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