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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 a medical device manufactured by ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2020-03-06 under approval 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. It is manufactured by ZetrOZ Systems, LLC. The 510(k) number is K191568.

When was sam 2.0 Long Duration Ultrasound System approved by the FDA?

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

What company makes sam 2.0 Long Duration Ultrasound System?

sam 2.0 Long Duration Ultrasound System is manufactured by ZetrOZ Systems, LLC.

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by ZetrOZ Systems, LLC

K211513sam X1 Long Duration Ultrasound Device K233210sam CS Long Duration Ultrasound Device K223019sam 2.0 Long Ultrasound Device K260076SAM 3.0 Multi-Hour Continuous Ultrasound Device

Related Devices (Code: PFW)

K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC K221210PainShield MD PLUSNanovibronix, Inc. K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC

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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