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FDA 510(k)

PERIOTYPE X-PERT

K-Number: K123386 · 2013-04-26

ApplicantClinical House Europe GmbH
Decision Date2013-04-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIOTYPE X-PERT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical House Europe GmbH. It received FDA 510(k) clearance on 2013-04-26 under 510(k) number K123386. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIOTYPE X-PERT?

PERIOTYPE X-PERT is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Clinical House Europe GmbH. The 510(k) number is K123386.

When did PERIOTYPE X-PERT receive FDA 510(k) clearance?

PERIOTYPE X-PERT received FDA 510(k) clearance on 2013-04-26, under 510(k) number K123386.

Who is the listed applicant for PERIOTYPE X-PERT?

The FDA 510(k) record lists Clinical House Europe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIOTYPE X-PERT?

The FDA product code for PERIOTYPE X-PERT is DZE.

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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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