CEROX— 510(k) K131854

Substantially Equivalent

Or-Nim Medical , Ltd.

FDA 510(k) clearance K131854 for CEROX, Substantially Equivalent on 2013-09-13. Applicant: Or-Nim Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Or-Nim Medical , Ltd.
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2013-06-21
Decision date: 2013-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPW

K260700 — BlueDop Vascular Expert2026-07-08
K252810 — FloPatch FP1202026-04-24
K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more2025-11-20
K251114 — FloPatch FP1202025-06-20
K243852 — Elfor-L2025-04-14

More clearances from Or-Nim Medical , Ltd.

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