Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

sam X1 Long Duration Ultrasound Device

K-Number: K211513 · 2021-08-18

ApplicantZetrOZ Systems, LLC
Decision Date2021-08-18
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

sam X1 Long Duration Ultrasound Device is a medical device manufactured by ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2021-08-18 under approval number K211513. 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 X1 Long Duration Ultrasound Device?

sam X1 Long Duration Ultrasound Device is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by ZetrOZ Systems, LLC. The 510(k) number is K211513.

When was sam X1 Long Duration Ultrasound Device approved by the FDA?

sam X1 Long Duration Ultrasound Device received FDA 510(k) clearance on 2021-08-18, under approval number K211513.

What company makes sam X1 Long Duration Ultrasound Device?

sam X1 Long Duration Ultrasound Device is manufactured by ZetrOZ Systems, LLC.

What is the FDA product code for sam X1 Long Duration Ultrasound Device?

The FDA product code for sam X1 Long Duration Ultrasound Device is PFW.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED

Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025)

Other Devices by ZetrOZ Systems, LLC

K191568sam 2.0 Long Duration Ultrasound System K233210sam CS Long Duration Ultrasound Device K223019sam 2.0 Long Ultrasound Device K260076SAM 3.0 Multi-Hour Continuous Ultrasound Device

Related Devices (Code: PFW)

K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ 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.

↑