Sam X1 Long Duration Ultrasound Device

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 X1 Long Duration Ultrasound Device.

Pre-market Notification Details

Device IDK211513
510k NumberK211513
Device Name:Sam X1 Long Duration Ultrasound Device
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
ZetrOZ Systems, LLC 56 Quarry Road Trumbull,  CT  06611
Product CodePFW  
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-14
Decision Date2021-08-18

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