MiniOx 1000 Oxygen Concentration Indicator
510(k) K935364
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935364 | Date14 Jun 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CCL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MiniOx 1000 Oxygen Concentration Indicator is a gaseous-phase oxygen analyzer designed to measure and display the concentration of oxygen in gas mixtures. As a Class II device, it is intended for use in clinical settings where precise oxygen monitoring is required, particularly in anesthesia and respiratory care applications.
This device is supplied as a reusable instrument and is intended for use in controlled environments such as operating rooms or critical care units. It operates on the principle of electrochemical sensing to provide accurate oxygen concentration readings, typically expressed in percentage terms. The MiniOx 1000 has received FDA 510(k) clearance under the classification CCL (Clinical Laboratory Reagents and Related Items) and is regulated under the regulation number 868.1720. No specific sterility or MRI safety information is provided in the data.
Other devices from Minesafety Appliances Co.
Questions
AI-generated answers, 1 Oct 2026
What is the MiniOx 1000 Oxygen Concentration Indicator used for?
The MiniOx 1000 is designed to measure and display the concentration of oxygen in gas mixtures, making it ideal for clinical settings like operating rooms and critical care units. Its primary purpose is to ensure accurate oxygen monitoring during anesthesia and respiratory care procedures, where precise gas composition is critical for patient safety.
Is the MiniOx 1000 a single-use or reusable device?
The MiniOx 1000 is a reusable instrument. It is intended for repeated use in controlled clinical environments, such as operating rooms or intensive care units, where consistent oxygen monitoring is essential. Reusability helps maintain cost efficiency and reliability in high-stakes medical settings.
How does the MiniOx 1000 measure oxygen concentration?
The MiniOx 1000 uses electrochemical sensing technology to detect and quantify oxygen levels in gas mixtures. This method provides real-time, accurate readings of oxygen concentration, typically expressed as a percentage. The device’s design ensures reliable performance in clinical applications where precise monitoring is required.
What regulatory approval does the MiniOx 1000 have?
The MiniOx 1000 has received FDA 510(k) clearance under the Clinical Laboratory Reagents and Related Items (CCL) classification. This approval confirms that the device meets regulatory standards for safety and effectiveness in its intended clinical use, specifically for oxygen concentration measurement in anesthesia and respiratory care.
Does the MiniOx 1000 require any special storage conditions?
While the device data does not specify detailed storage requirements, reusable medical devices like the MiniOx 1000 generally require proper handling to maintain accuracy and sterility. This typically includes storage in a clean, dry environment, away from extreme temperatures or direct sunlight, and adherence to manufacturer guidelines for calibration and maintenance to ensure reliable performance.