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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
510(k) Number K211513
Device Name sam X1 Long Duration Ultrasound Device
Applicant
ZetrOZ Systems, LLC
56 Quarry Rd.
Trumbull,  CT  06611
Applicant Contact Sabrina Lewis
Correspondent
ZetrOZ Systems, LLC
56 Quarry Rd.
Trumbull,  CT  06611
Correspondent Contact Sabrina Lewis
Regulation Number890.5300
Classification Product Code
PFW  
Date Received05/14/2021
Decision Date 08/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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