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Mark 5 Nuvo 8 OCSI, Mark 5 Nuvo 8 STD

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K093308

by Nidek Medical Products Inc.

Identifiers

510(k) Number
K093308 FDA 510(k)
FDA Product Code
CAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5440 FDA 510(k)
Regulation Number
868.5440 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mark 5 Nuvo 8 OCSI and Mark 5 Nuvo 8 STD are portable oxygen generators designed to deliver medical-grade oxygen for patient use. These devices are classified as oxygen generators and are intended for use in anesthesiology settings, providing a reliable source of oxygen during surgical and procedural interventions.

These devices are supplied as reusable medical equipment, regulated under FDA 510K and MDR authorizations, and are intended for use in clinical environments. They are not single-use and require proper maintenance and calibration to ensure safe and accurate oxygen delivery. The devices are classified as Class II under FDA regulations and comply with the regulatory requirements outlined in 868.5440. No specific sterility or MRI safety information is provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nidek Medical Products Inc.
FDA Applicant
Nidek Medical Products, Inc.

Sources (2)

  • FDA 510(k) K093308 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026