ZTX ULTRASONIC DIATHERMY DEVICE— 510(k) K130978

Substantially Equivalent

Zetroz, Inc.

FDA 510(k) clearance K130978 for ZTX ULTRASONIC DIATHERMY DEVICE, Substantially Equivalent on 2013-11-06. Applicant: Zetroz, Inc.. Device class: 2.

Clearance details

Applicant: Zetroz, Inc.
Product code: Code PFW
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2013-04-09
Decision date: 2013-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trumbull, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.