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Mark 5 Nuvo OCSI (M5C5), Models 505 and 905

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040892

by Nidek Medical Products Inc.

Identifiers

510(k) Number
K040892 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 OCSI (M5C5) is a portable oxygen generator designed for use in anesthesia. It delivers concentrated oxygen to patients during surgical or procedural interventions, ensuring a reliable supply of medical-grade oxygen in clinical settings.

This device is intended for single-use or reusable applications within anesthesia workflows, adhering to FDA 510(k) clearance under classification CAW and regulation 868.5440. Supplied as a portable unit, it is regulated for use in anesthesia environments and requires proper storage and maintenance as specified in manufacturer guidelines. The device holds FDA clearance (K040892) with a decision date of April 29, 2004.

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. Sources consulted: MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 (K040892) — FDA 510(k ..., MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 510(k)… - FDA.report, 510 (k) Premarket Notification, NIDEK MEDICAL MARK 5 NUVO M5C5 USER MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

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

Sources (1)

  • FDA 510(k) K040892 24 fields · synced Oct 6, 2026