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FDA 510(k)

VOLISTA 400; VOLISTA 600

K-Number: K130513 · 2013-05-08

ApplicantMaquet S.A.S.
Decision Date2013-05-08
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VOLISTA 400; VOLISTA 600 is the device name listed in this FDA 510(k) record. The listed applicant is Maquet S.A.S.. It received FDA 510(k) clearance on 2013-05-08 under 510(k) number K130513. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLISTA 400; VOLISTA 600?

VOLISTA 400; VOLISTA 600 is a medical device that received FDA 510(k) clearance on 2013-05-08. The listed applicant is Maquet S.A.S.. The 510(k) number is K130513.

When did VOLISTA 400; VOLISTA 600 receive FDA 510(k) clearance?

VOLISTA 400; VOLISTA 600 received FDA 510(k) clearance on 2013-05-08, under 510(k) number K130513.

Who is the listed applicant for VOLISTA 400; VOLISTA 600?

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

What is the FDA product code for VOLISTA 400; VOLISTA 600?

The FDA product code for VOLISTA 400; VOLISTA 600 is FTD.

Related Clinical Trials

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Other records listing Maquet S.A.S. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113679LUCEA LED SURGICAL LIGHT SYSTEM

Related Devices (Code: FTD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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