SAM 3.0 Multi-Hour Continuous Ultrasound Device— 510(k) K260076

Name: FDA 510(k) clearance K260076
Creator: U.S. Food and Drug Administration
Published: 2026-04-28

Substantially Equivalent

ZetrOZ Systems, LLC

FDA 510(k) clearance K260076 for SAM 3.0 Multi-Hour Continuous Ultrasound Device, Substantially Equivalent on 2026-04-28. Applicant: ZetrOZ Systems, LLC. Device class: 2.

Clearance details

Applicant: ZetrOZ Systems, LLC
Product code: Code PFW
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2026-01-12
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Trumbull, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PFW

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K233210 — sam CS Long Duration Ultrasound Device2023-10-25
K223019 — sam 2.0 Long Ultrasound Device2023-06-23
K221210 — PainShield MD PLUS2022-11-23
K211513 — sam X1 Long Duration Ultrasound Device2021-08-18
K191568 — sam 2.0 Long Duration Ultrasound System2020-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.