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510(k) K130978

ZTX ULTRASONIC DIATHERMY DEVICE by Zetroz, Inc. — Product Code PFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2013
Date Received
April 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

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