Multichannel Telemetry System
by Burdick Corp. 510(k)
Active
510(k) K801944
Overview
The Multichannel Telemetry System is a Transmitters and Receivers, Physiological Signal, Radiofrequency device, designed to wirelessly transmit and receive physiological signals for monitoring purposes. It facilitates real-time data acquisition from multiple channels, enabling continuous assessment of cardiovascular parameters in clinical settings. This system is classified under the OpenFDA category for cardiovascular applications and operates within the regulatory framework for radiofrequency-based telemetry devices.
This device is intended for use in clinical environments, where it transmits physiological signals wirelessly for monitoring. It is classified as a Class II medical device under FDA regulations (870.2910) and has received FDA 510(k) clearance (K801944) as substantially equivalent to predicate devices. Supplied as a reusable system, it requires proper calibration and maintenance to ensure accurate signal transmission and reception. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801944 | Date23 Oct 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2910
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Burdick Corp.
Questions
What is the Burdick Multichannel Telemetry System used for?
The Burdick Multichannel Telemetry System is designed to wirelessly transmit and receive physiological signals, enabling continuous monitoring of cardiovascular parameters in clinical settings. It facilitates real-time data acquisition from multiple channels, which is particularly useful for assessing heart function and other vital signs during patient care.
Is the Multichannel Telemetry System reusable or single-use?
The Multichannel Telemetry System is supplied as a reusable device. To ensure accurate and reliable performance, it requires proper calibration and maintenance as part of its operational protocol. Reusability is common for telemetry systems to reduce costs and environmental impact while maintaining clinical utility.
Does the Multichannel Telemetry System require sterilization?
The available data does not specify any sterility requirements for the Burdick Multichannel Telemetry System. Since it is reusable and intended for clinical use, proper cleaning and maintenance protocols should be followed to prevent contamination. If used in invasive procedures or high-risk environments, additional sterilization steps may be necessary, though this is not explicitly mentioned in the provided details.
What regulatory approval does the Multichannel Telemetry System hold?
The Burdick Multichannel Telemetry System has received FDA 510(k) clearance (K801944) as substantially equivalent to predicate devices. It is classified under the OpenFDA category for cardiovascular applications and operates within the regulatory framework for radiofrequency-based telemetry devices, specifically under FDA classification 870.2910 for Class II medical devices.
Are there different models or configurations available for the Multichannel Telemetry System?
The system is associated with multiple registration numbers and FEI numbers, indicating it may support various configurations or accessories. However, the provided data does not specify distinct models or variations beyond its core function as a wireless physiological signal transmitter and receiver. For precise details on available configurations, refer to Burdick Corp.’s technical documentation or contact their support team.