Telemetry Decoder #540-02

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K823678 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What clinical setting is the Telemetry Decoder #540-02 designed for, and how does it support patient monitoring?

  The Telemetry Decoder #540-02 is specifically designed for use in cardiovascular clinical environments where implantable pacemaker pulse-generators are evaluated. It decodes and interprets telemetry signals transmitted from these devices, enabling healthcare providers to monitor and assess pacemaker function in real-time. This aids in diagnosing issues, verifying proper operation, and ensuring patient safety during follow-up visits or emergencies.

• Is the Telemetry Decoder #540-02 intended for single-use or reusable applications, and what does this mean for maintenance?

  The Telemetry Decoder #540-02 is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings. Since it is not sterile, proper cleaning, disinfection, and maintenance protocols must be followed per standard reusable medical device guidelines to ensure reliability and prevent contamination between uses.

• How should the Telemetry Decoder #540-02 be stored, and are there any special handling requirements?

  The device follows standard storage and handling protocols for reusable diagnostic equipment. It should be stored in a clean, dry environment, protected from physical damage, and kept away from sources of electromagnetic interference. Since it is not sterile, it should not be stored in a manner that compromises its functionality or introduces contamination risks.

• What regulatory pathway was followed for FDA clearance, and what does this mean for its use in healthcare?

  The Telemetry Decoder #540-02 received FDA 510(k) clearance (K823678) under the Cardiovascular advisory committee, classified as substantially equivalent to a predicate device. This means it has been evaluated and determined to meet FDA safety and performance standards for use with implantable pacemaker pulse-generators, ensuring its suitability for clinical monitoring in cardiovascular settings.