MobileDiagnost wDR 2.2
K-Number: K191813 · 2019-08-02
ApplicantSedecal., Sa.
Decision Date2019-08-02
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MobileDiagnost wDR 2.2 is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2019-08-02 under approval number K191813. 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 MobileDiagnost wDR 2.2?
MobileDiagnost wDR 2.2 is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Sedecal., Sa.. The 510(k) number is K191813.
When was MobileDiagnost wDR 2.2 approved by the FDA?
MobileDiagnost wDR 2.2 received FDA 510(k) clearance on 2019-08-02, under approval number K191813.
What company makes MobileDiagnost wDR 2.2?
MobileDiagnost wDR 2.2 is manufactured by Sedecal., Sa..
What is the FDA product code for MobileDiagnost wDR 2.2?
The FDA product code for MobileDiagnost wDR 2.2 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.