Mark 5 Nuvo Lite Ocsi And Std

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K082566

Identifiers

510(k) Number: K082566 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 Lite is a portable oxygen generator designed for use in anesthesia procedures. It delivers precise oxygen concentrations to support patient respiration during surgical interventions, ensuring reliable gas supply in clinical settings.

Supplied as a reusable device, the Mark 5 Nuvo Lite is intended for use in operating rooms and anesthesia workstations. It operates under regulatory authorizations including FDA 510K clearance and compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is classified as Class II under FDA regulations and adheres to registration number 868.5440 for portable oxygen generators.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K082566	Class II	Active

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Manufacturer

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

Sources (2)

FDA 510(k) K082566 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026