Single Channel Non-Fade Oscilloscope
by Quinton, Inc. 510(k)
Active
510(k) K811911
Overview
The Single Channel Non-Fade Oscilloscope is a cathode-ray tube medical display device designed to visually represent electrical signals, such as those from cardiac monitoring. It falls under the classification of Display, Cathode-Ray Tube, Medical and is intended for use in cardiovascular applications, providing real-time waveform visualization without signal degradation over time.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K811911 and K822517) with a classification of Class II (21 CFR 870.2450). It is intended for use in clinical settings where stable, long-duration waveform display is required, such as in electrocardiogram (ECG) monitoring. The device is not single-use and does not require sterilization between uses. No MRI safety information is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811911 | Date28 Jul 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the Quinton Single Channel Non-Fade Oscilloscope used for?
This device is designed to visually represent electrical signals, particularly in cardiovascular applications. It is specifically intended for real-time waveform visualization during electrocardiogram (ECG) monitoring, ensuring stable and uninterrupted display of cardiac signals over extended periods without signal degradation.
Is the Quinton Single Channel Non-Fade Oscilloscope single-use or reusable?
The device is a reusable medical instrument. It is not intended for single-use and does not require sterilization between uses, simplifying its maintenance and operational workflow in clinical settings.
Does this oscilloscope require any special storage conditions?
The device specifications do not explicitly mention special storage conditions. However, as a reusable medical instrument, it should be stored in a clean, dry environment to prevent contamination or damage. Always follow manufacturer guidelines for optimal performance and longevity.
What regulatory approval does the Quinton Single Channel Non-Fade Oscilloscope hold?
The device is regulated under the FDA 510(k) clearance pathway with the classification of Class II (21 CFR 870.2450). It holds clearance numbers K811911 and K822517, confirming its substantial equivalence to a predicate device for use in medical applications.
Can this oscilloscope be used in MRI environments?
The specifications for the Quinton Single Channel Non-Fade Oscilloscope do not provide any MRI safety information. Therefore, it should not be assumed safe for use in MRI environments without explicit confirmation from the manufacturer or additional safety assessments.