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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K191436
Device Name Saalio
Applicant
Saalmann Medical GmbH & Co. KG
Sudbahnstrabe 34
Bad Oeynhausen,  DE 32547
Applicant Contact Rolf Eilers
Correspondent
Beo Medconsulting Berlin GmbH
Helmholtzstr. 2
Berlin,  DE 10587
Correspondent Contact Michael Vent
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received05/30/2019
Decision Date 10/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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