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FDA 510(k)

UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)

K-Number: K053172 · 2006-06-09

ApplicantOwandy Sas
Decision Date2006-06-09
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) is the device name listed in this FDA 510(k) record. The listed applicant is Owandy Sas. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K053172. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)?

UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Owandy Sas. The 510(k) number is K053172.

When did UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) receive FDA 510(k) clearance?

UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) received FDA 510(k) clearance on 2006-06-09, under 510(k) number K053172.

Who is the listed applicant for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)?

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

What is the FDA product code for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)?

The FDA product code for UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) is MUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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