Saalio— 510(k) K191436

Substantially Equivalent

Saalmann Medical GmbH & Co. KG

FDA 510(k) clearance K191436 for Saalio, Substantially Equivalent on 2019-10-18. Applicant: Saalmann Medical GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Saalmann Medical GmbH & Co. KG
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2019-05-30
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Oeynhausen, DE

Download summary PDF View on FDA.gov ↗

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