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FDA 510(k)

EUROMI EVA SP6

K-Number: K101413 · 2010-12-16

ApplicantEuromi S.A
Decision Date2010-12-16
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EUROMI EVA SP6 is the device name listed in this FDA 510(k) record. The listed applicant is Euromi S.A. It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K101413. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROMI EVA SP6?

EUROMI EVA SP6 is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Euromi S.A. The 510(k) number is K101413.

When did EUROMI EVA SP6 receive FDA 510(k) clearance?

EUROMI EVA SP6 received FDA 510(k) clearance on 2010-12-16, under 510(k) number K101413.

Who is the listed applicant for EUROMI EVA SP6?

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

What is the FDA product code for EUROMI EVA SP6?

The FDA product code for EUROMI EVA SP6 is QPB.

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Other records listing Euromi S.A 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.

K010311LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE

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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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