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FDA 510(k)

PRAEZIS PLUS

K-Number: K110644 · 2012-05-24

ApplicantTatramed Spol. S.R.O.
Decision Date2012-05-24
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRAEZIS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Tatramed Spol. S.R.O.. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K110644. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRAEZIS PLUS?

PRAEZIS PLUS is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Tatramed Spol. S.R.O.. The 510(k) number is K110644.

When did PRAEZIS PLUS receive FDA 510(k) clearance?

PRAEZIS PLUS received FDA 510(k) clearance on 2012-05-24, under 510(k) number K110644.

Who is the listed applicant for PRAEZIS PLUS?

The FDA 510(k) record lists Tatramed Spol. S.R.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRAEZIS PLUS?

The FDA product code for PRAEZIS PLUS is HAW.

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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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