MobileDiagnost wDR 2.2
K-Number: K191813 · 2019-08-02
Device Summary
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. The listed applicant is Sedecal., Sa.. The 510(k) number is K191813.
When did MobileDiagnost wDR 2.2 receive FDA 510(k) clearance?
MobileDiagnost wDR 2.2 received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191813.
Who is the listed applicant for MobileDiagnost wDR 2.2?
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 MobileDiagnost wDR 2.2?
The FDA product code for MobileDiagnost wDR 2.2 is IZL.
Other records listing Sedecal., Sa. 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.
Related Devices (Code: IZL)
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.
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.