Propaq ECG Telemetry Option
510(k) K934711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934711 | Date1 Sep 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- Withdrawn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
- DRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2910
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Propaq ECG Telemetry Option is a device that transmits and receives physiological signals, specifically ECG telemetry, using radiofrequency technology. It is designed for cardiovascular applications and is part of the Propaq series of monitoring systems.
This device is supplied as part of the Propaq monitoring system and is intended for use in clinical settings. It is a Class II device that received FDA 510(k) clearance in 1994 under product code DRG and regulation number 870.2910. The device is not specified as single-use or reusable, and no MRI safety information is provided in the data.
Other devices from Protocol Systems, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the PROPAQ ECG Telemetry Option used for?
The PROPAQ ECG Telemetry Option is designed to transmit and receive physiological signals, specifically ECG telemetry, using radiofrequency technology. It is intended for cardiovascular applications and is part of the Propaq series of monitoring systems used in clinical settings.
Is the PROPAQ ECG Telemetry Option single-use or reusable?
The device data does not specify whether the PROPAQ ECG Telemetry Option is single-use or reusable. It is supplied as part of the Propaq monitoring system and is a Class II device that received FDA 510(k) clearance in 1994.
What regulatory approvals does the PROPAQ ECG Telemetry Option have?
The PROPAQ ECG Telemetry Option is a Class II device that received FDA 510(k) clearance in 1994 under product code DRG and regulation number 870.2910. It was determined to be substantially equivalent to other devices on the market.
How is the PROPAQ ECG Telemetry Option supplied?
The PROPAQ ECG Telemetry Option is supplied as part of the Propaq monitoring system. It is designed for use in clinical settings and integrates with the Propaq series of monitoring systems to provide cardiovascular monitoring capabilities.