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FDA 510(k)

Soltus 500

K-Number: K192936 · 2019-11-15

ApplicantSedecal., Sa.
Decision Date2019-11-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Soltus 500 is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192936. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soltus 500?

Soltus 500 is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Sedecal., Sa.. The 510(k) number is K192936.

When did Soltus 500 receive FDA 510(k) clearance?

Soltus 500 received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192936.

Who is the listed applicant for Soltus 500?

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

What is the FDA product code for Soltus 500?

The FDA product code for Soltus 500 is IZL.

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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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