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FDA 510(k)

OPTIMA MX

K-Number: K042759 · 2004-10-20

ApplicantBien-Air SA Switzerland
Decision Date2004-10-20
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIMA MX is the device name listed in this FDA 510(k) record. The listed applicant is Bien-Air SA Switzerland. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042759. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMA MX?

OPTIMA MX is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Bien-Air SA Switzerland. The 510(k) number is K042759.

When did OPTIMA MX receive FDA 510(k) clearance?

OPTIMA MX received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042759.

Who is the listed applicant for OPTIMA MX?

The FDA 510(k) record lists Bien-Air SA Switzerland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMA MX?

The FDA product code for OPTIMA MX is EIA.

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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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