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FDA 510(k)

ZTX ULTRASONIC DIATHERMY DEVICE

K-Number: K130978 · 2013-11-06

ApplicantZetroz, Inc.
Decision Date2013-11-06
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ZTX ULTRASONIC DIATHERMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zetroz, Inc.. It received FDA 510(k) clearance on 2013-11-06 under 510(k) number K130978. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZTX ULTRASONIC DIATHERMY DEVICE?

ZTX ULTRASONIC DIATHERMY DEVICE is a medical device that received FDA 510(k) clearance on 2013-11-06. The listed applicant is Zetroz, Inc.. The 510(k) number is K130978.

When did ZTX ULTRASONIC DIATHERMY DEVICE receive FDA 510(k) clearance?

ZTX ULTRASONIC DIATHERMY DEVICE received FDA 510(k) clearance on 2013-11-06, under 510(k) number K130978.

Who is the listed applicant for ZTX ULTRASONIC DIATHERMY DEVICE?

The FDA 510(k) record lists Zetroz, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZTX ULTRASONIC DIATHERMY DEVICE?

The FDA product code for ZTX ULTRASONIC DIATHERMY DEVICE is PFW.

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Related Devices (Code: PFW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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