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FDA 510(k)

Saalio

K-Number: K191436 · 2019-10-18

ApplicantSaalmann Medical GmbH & Co. KG
Decision Date2019-10-18
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Saalio is a medical device manufactured by Saalmann Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-18 under approval number K191436. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saalio?

Saalio is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Saalmann Medical GmbH & Co. KG. The 510(k) number is K191436.

When was Saalio approved by the FDA?

Saalio received FDA 510(k) clearance on 2019-10-18, under approval number K191436.

What company makes Saalio?

Saalio is manufactured by Saalmann Medical GmbH & Co. KG.

What is the FDA product code for Saalio?

The FDA product code for Saalio is EGJ.

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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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