FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The MX300 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the MX300 Oxygen Monitor, not a study report. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the MX300 is as safe and effective as a device already on the market, but it does not provide the specific performance data, acceptance criteria, or study details you've requested.

Therefore, I cannot populate the table or provide the requested information. To get this level of detail, one would typically need to refer to the actual 510(k) submission document or a study report conducted by the manufacturer.

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K Number

K024228

Device Name

RX300 OXYGEN ANALYZER

Manufacturer

TELEDYNE ANALYTICAL INSTRUMENTS

Date Cleared

2003-07-17

(206 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The AX300 is intended to accurately measure (spot check) and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding the clearance of a medical device, the AX300 Oxygen Analyzer. It details the regulatory classification and general information about marketing the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details related to proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a scientific study report.

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K Number

K001095

Device Name

OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130

Manufacturer

TELEDYNE ANALYTICAL INSTRUMENTS

Date Cleared

2000-06-30

(87 days)

Product Code