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 3.0 Multi-Hour Continuous Ultrasound Device

K-Number: K260076 · 2026-04-28

ApplicantZetrOZ Systems, LLC
Decision Date2026-04-28
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SAM 3.0 Multi-Hour Continuous Ultrasound Device is a medical device manufactured by ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2026-04-28 under approval number K260076. 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 3.0 Multi-Hour Continuous Ultrasound Device?

SAM 3.0 Multi-Hour Continuous Ultrasound Device is a medical device that received FDA 510(k) clearance on 2026-04-28. It is manufactured by ZetrOZ Systems, LLC. The 510(k) number is K260076.

When was SAM 3.0 Multi-Hour Continuous Ultrasound Device approved by the FDA?

SAM 3.0 Multi-Hour Continuous Ultrasound Device received FDA 510(k) clearance on 2026-04-28, under approval number K260076.

What company makes SAM 3.0 Multi-Hour Continuous Ultrasound Device?

SAM 3.0 Multi-Hour Continuous Ultrasound Device is manufactured by ZetrOZ Systems, LLC.

What is the FDA product code for SAM 3.0 Multi-Hour Continuous Ultrasound Device?

The FDA product code for SAM 3.0 Multi-Hour Continuous Ultrasound Device is PFW.

Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026)

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.

↑