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FDA 510(k)

VOLPARA, VERSION 1.3

K-Number: K102556 · 2010-10-07

ApplicantMatakina Technology Limited
Decision Date2010-10-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLPARA, VERSION 1.3 is the device name listed in this FDA 510(k) record. The listed applicant is Matakina Technology Limited. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K102556. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLPARA, VERSION 1.3?

VOLPARA, VERSION 1.3 is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Matakina Technology Limited. The 510(k) number is K102556.

When did VOLPARA, VERSION 1.3 receive FDA 510(k) clearance?

VOLPARA, VERSION 1.3 received FDA 510(k) clearance on 2010-10-07, under 510(k) number K102556.

Who is the listed applicant for VOLPARA, VERSION 1.3?

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

What is the FDA product code for VOLPARA, VERSION 1.3?

The FDA product code for VOLPARA, VERSION 1.3 is LLZ.

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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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