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FDA 510(k)

sam 2.0 Long Duration Ultrasound System

K-Number: K191568 · 2020-03-06

ApplicantZetrOZ Systems, LLC
Decision Date2020-03-06
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

sam 2.0 Long Duration Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K191568. 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 sam 2.0 Long Duration Ultrasound System?

sam 2.0 Long Duration Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is ZetrOZ Systems, LLC. The 510(k) number is K191568.

When did sam 2.0 Long Duration Ultrasound System receive FDA 510(k) clearance?

sam 2.0 Long Duration Ultrasound System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K191568.

Who is the listed applicant for sam 2.0 Long Duration Ultrasound System?

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

What is the FDA product code for sam 2.0 Long Duration Ultrasound System?

The FDA product code for sam 2.0 Long Duration Ultrasound System is PFW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07515872Long Duration High Frequency Ultrasound for the Treatment of OsteoarthritisNOT_YET_RECRUITING

Other records listing ZetrOZ Systems, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceK233210sam CS Long Duration Ultrasound DeviceK223019sam 2.0 Long Ultrasound DeviceK211513sam X1 Long Duration Ultrasound Device

Related Devices (Code: PFW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLCK233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLCK223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLCK221210PainShield MD PLUSNanovibronix, Inc.K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC

Official Source

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

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