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FDA 510(k)

Oxi-W System

K-Number: K200141 · 2020-04-27

ApplicantLd Technology, LLC
Decision Date2020-04-27
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oxi-W System is a medical device manufactured by Ld Technology, LLC. It received FDA 510(k) clearance on 2020-04-27 under approval 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. It is manufactured by Ld Technology, LLC. The 510(k) number is K200141.

When was Oxi-W System approved by the FDA?

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

What company makes Oxi-W System?

Oxi-W System is manufactured by Ld Technology, LLC.

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

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

Other Devices by Ld Technology, LLC

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

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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.

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