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FDA 510(k)

CERASYS - ZR

K-Number: K042548 · 2004-12-03

ApplicantCerasys, Inc.
Decision Date2004-12-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERASYS - ZR is the device name listed in this FDA 510(k) record. The listed applicant is Cerasys, Inc.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042548. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERASYS - ZR?

CERASYS - ZR is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Cerasys, Inc.. The 510(k) number is K042548.

When did CERASYS - ZR receive FDA 510(k) clearance?

CERASYS - ZR received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042548.

Who is the listed applicant for CERASYS - ZR?

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

What is the FDA product code for CERASYS - ZR?

The FDA product code for CERASYS - ZR is EIH.

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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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