EC50 TOXCO+ Breath Carbon Monoxide Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070259 FDA 510(k)
- FDA Product Code
- CCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1430 FDA 510(k)
- Regulation Number
- 868.1430 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EC50 TOXCO+ Breath Carbon Monoxide Monitor is a device used to measure carbon monoxide levels in breath samples. It is designed for use in medical settings to assess potential carbon monoxide poisoning in patients.
This monitor is used by healthcare professionals in medical institutions and emergency medical services for pediatric, adult, and unconscious patients. The device is supplied with accessories and requires proper storage and handling according to the manufacturer's instructions. It has received FDA 510(k) clearance with the product code CCJ and is classified as a Class II device.
Frequently asked questions
What is the EC50 TOXCO+ Breath Carbon Monoxide Monitor used for?
The EC50 TOXCO+ Breath Carbon Monoxide Monitor is used by healthcare professionals in medical settings to measure carbon monoxide levels in breath samples, helping to assess potential carbon monoxide poisoning in patients including pediatric, adult, and unconscious individuals.
How is the EC50 TOXCO+ Monitor supplied and what are its storage requirements?
The monitor is supplied with accessories and requires proper storage and handling according to the manufacturer's instructions to ensure accurate readings and device longevity. Healthcare professionals should follow Bedfont Scientific Ltd.'s specific guidelines for storage conditions.
What is the regulatory status of the EC50 TOXCO+ Monitor?
The EC50 TOXCO+ Breath Carbon Monoxide Monitor has received FDA 510(k) clearance with the product code CCJ and is classified as a Class II device. It was determined to be substantially equivalent through the traditional clearance process.
Can the EC50 TOXCO+ Monitor be used for different patient types?
Yes, the monitor is designed for use with pediatric, adult, and unconscious patients in medical institutions and emergency medical services, making it versatile for various clinical settings where carbon monoxide poisoning assessment is needed.
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: BEDFONT EC50 TOXCO INSTRUCTION MANUAL Pdf Download, BEDFONT TOXCO USER MANUAL Pdf Download | ManualsLib, Ec50 Toxco+ Breath Carbon Monoxide Monitor, ToxCO Manuals - Bedfont Scientific Ltd. Resources
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070259 | Class II | Active |
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Manufacturer
- Manufacturer
- Bedfont Scientific Ltd
- FDA Applicant
- Bedfont Scientific, Ltd.
Sources (1)
- FDA 510(k) K070259 24 fields · synced Oct 6, 2026