Sam 2.0 Long Duration Ultrasound System

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

ZetrOZ Systems, LLC

The following data is part of a premarket notification filed by Zetroz Systems, Llc with the FDA for Sam 2.0 Long Duration Ultrasound System.

Pre-market Notification Details

Device IDK191568
510k NumberK191568
Device Name:Sam 2.0 Long Duration Ultrasound System
ClassificationStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Applicant ZetrOZ Systems, LLC 56 Quarry Road Trumbull,  CT  06611
ContactSabrina Lewis
CorrespondentSabrina Lewis
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodePFW  
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2020-03-06

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