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Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111773

by Renu Medical, Inc

Identifiers

510(k) Number
K111773 FDA 510(k)
FDA Product Code
NLF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Renu Medical Reprocessed Oximax Sensors are oximeters, a type of medical device used to measure oxygen saturation in the blood. They are available in various sizes, including adult, pediatric, infant, and neonate. These sensors are reprocessed, meaning they are cleaned, tested, and restored for reuse. The device is classified as a cardiovascular device, indicating its intended use in monitoring patients with cardiovascular conditions.

The Renu Medical Reprocessed Oximax Sensors are supplied in various sizes to accommodate different patient populations. They are regulated under the FDA's 510K clearance, with a decision code of SESE, indicating substantial equivalence to a predicate device. The device is assigned a product code of NLF and a regulation number of 870.2700, and is registered with the FDA under several registration numbers. The sensors are designed for use in a clinical setting, and their storage and handling instructions are not specified in the provided data.

Frequently asked questions

What are the Renu Medical Reprocessed Oximax Sensors used for?

The Renu Medical Reprocessed Oximax Sensors are used to measure oxygen saturation in the blood, particularly in patients with cardiovascular conditions.

What sizes are the Renu Medical Reprocessed Oximax Sensors available in?

The Renu Medical Reprocessed Oximax Sensors are available in various sizes, including adult, pediatric, infant, and neonate, to accommodate different patient populations.

Are the Renu Medical Reprocessed Oximax Sensors single-use or reusable?

The Renu Medical Reprocessed Oximax Sensors are reprocessed, meaning they are cleaned, tested, and restored for reuse.

What regulatory clearance do the Renu Medical Reprocessed Oximax Sensors have?

The Renu Medical Reprocessed Oximax Sensors are regulated under the FDA's 510K clearance, with a decision code of SESE, indicating substantial equivalence to a predicate device.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Renu Medical, Inc
FDA Applicant
Renu Medical, Inc.

Sources (1)

  • FDA 510(k) K111773 24 fields · synced Oct 6, 2026