Quinton Q-TE RMS
by Quinton Cardiology, Inc. 510(k)
Active
510(k) K041607
Overview
The Quinton Q-TE RMS is a physiological patient monitor designed for arrhythmia detection and alarm functionality. Classified as a Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms), it continuously monitors cardiac activity to identify abnormal rhythms and trigger alerts, supporting clinical assessment and intervention in cardiovascular settings.
This device is used in clinical environments for real-time ECG waveform display and arrhythmia monitoring, with programmable alarms for signal loss. Supplied as a reusable system, it transmits patient data wirelessly via a body-worn RF transmitter to a central monitoring station. The Quinton Q-TE RMS operates under FDA 510(k) clearance (K041607) and is regulated under the classification MHX, with no third-party involvement in its submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041607 | Date16 Jul 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1818-2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Specification
- 510(k) Number
- FDA Product Code
- MHX
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Quinton Q-TE RMS used for in clinical settings?
The Quinton Q-TE RMS is a physiological patient monitor designed specifically for arrhythmia detection and alarm functionality. It continuously monitors cardiac activity via real-time ECG waveform display, helping clinicians identify abnormal heart rhythms. Programmable alarms for signal loss further enhance patient safety by ensuring timely clinical assessment and intervention in cardiovascular care environments.
How is the Quinton Q-TE RMS supplied and is it reusable?
The Quinton Q-TE RMS is supplied as a reusable system. This means it is intended for repeated use across multiple patients after proper cleaning, maintenance, and sterilization procedures as outlined by the manufacturer. Reusability helps reduce waste and costs while maintaining reliable performance for continuous cardiac monitoring.
Does the Quinton Q-TE RMS transmit patient data wirelessly, and how does it work?
Yes, the Quinton Q-TE RMS transmits patient data wirelessly using a body-worn RF (radio frequency) transmitter. This transmitter sends real-time cardiac monitoring information to a central monitoring station, enabling clinicians to remotely observe ECG waveforms and arrhythmia alerts. This wireless capability enhances flexibility in patient care settings, particularly in areas where wired systems may be impractical.
What regulatory approval does the Quinton Q-TE RMS hold, and how does it classify under FDA guidelines?
The Quinton Q-TE RMS holds FDA 510(k) clearance under the classification MHX, which falls under the Cardiovascular advisory committee. The device was determined to be substantially equivalent to a predicate product through an abbreviated review process, meaning it meets the same performance standards as previously approved monitors for arrhythmia detection and alarms. This clearance ensures compliance with U.S. regulatory requirements for physiological patient monitoring devices.
Are there different models or sizes available for the Quinton Q-TE RMS?
The provided data does not specify multiple models or sizes for the Quinton Q-TE RMS, indicating it is likely offered as a single, standardized system for clinical use. However, the device supports various configurations of ECG leads and wireless transmission, which may accommodate different patient monitoring needs. For precise sizing or model variations, refer to the manufacturer’s technical specifications or consult their support team.