FDA 510(k)

Saalio

K-Number: K191436 · 2019-10-18

Decision Date2019-10-18

Product CodeEGJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Saalio is the device name listed in this FDA 510(k) record. The listed applicant is Saalmann Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-18 under 510(k) 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. The listed applicant is Saalmann Medical GmbH & Co. KG. The 510(k) number is K191436.

When did Saalio receive FDA 510(k) clearance?

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

Who is the listed applicant for Saalio?

The FDA 510(k) record lists Saalmann Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saalio?

The FDA product code for Saalio is EGJ.

Related Devices (Code: EGJ)

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.

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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.