FDA 510(k)

Skanmobile, Skanmobile-Dr

K-Number: K212940 · 2022-03-04

Decision Date2022-03-04

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Skanmobile, Skanmobile-Dr is a medical device manufactured by Skanray Technologies Limited. It received FDA 510(k) clearance on 2022-03-04 under approval number K212940. 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 Skanmobile, Skanmobile-Dr?

Skanmobile, Skanmobile-Dr is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Skanray Technologies Limited. The 510(k) number is K212940.

When was Skanmobile, Skanmobile-Dr approved by the FDA?

Skanmobile, Skanmobile-Dr received FDA 510(k) clearance on 2022-03-04, under approval number K212940.

What company makes Skanmobile, Skanmobile-Dr?

Skanmobile, Skanmobile-Dr is manufactured by Skanray Technologies Limited.

What is the FDA product code for Skanmobile, Skanmobile-Dr?

The FDA product code for Skanmobile, Skanmobile-Dr is IZL.

Other Devices by Skanray Technologies Limited

K220518SKANRAD 400 K231761PodSKAN HF Diagnostic X-ray System K251893SKAN C PULSAR

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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.