FDA 510(k)

Oxi-W System

K-Number: K200141 · 2020-04-27

Decision Date2020-04-27

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Oxi-W System is the device name listed in this FDA 510(k) record. The listed applicant is Ld Technology, LLC. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200141. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxi-W System?

Oxi-W System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Ld Technology, LLC. The 510(k) number is K200141.

When did Oxi-W System receive FDA 510(k) clearance?

Oxi-W System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200141.

Who is the listed applicant for Oxi-W System?

The FDA 510(k) record lists Ld Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxi-W System?

The FDA product code for Oxi-W System is MWI.

Other records listing Ld Technology, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200287BP-BT Kiosk K173696TBL-ABI System K160956LD-Oxi system

Related Devices (Code: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.