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 a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2019-11-15 under approval 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. It is manufactured by Sedecal., Sa.. The 510(k) number is K192936.
When was Soltus 500 approved by the FDA?
Soltus 500 received FDA 510(k) clearance on 2019-11-15, under approval number K192936.
What company makes Soltus 500?
Soltus 500 is manufactured by Sedecal., Sa..
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.