Dialog Programmer 700 - Program Version 6.37
by Pacesetter Systems 510(k)
Active
510(k) K860546
Overview
The Dialog Programmer 700 is a medical device classified as a Programmer, Pacemaker (product code KRG), designed for programming and configuring implantable pacemaker systems. It facilitates adjustments to pacing parameters, such as heart rate, output, and timing, to ensure proper cardiac function in patients with pacemaker-dependent arrhythmias or conduction disorders.
This device is intended for use in clinical settings by trained healthcare professionals, including cardiologists and electrophysiologists. Supplied as a reusable electronic system, it requires proper calibration and maintenance per manufacturer guidelines. The Dialog Programmer 700 holds an FDA 510(k) clearance (K860546) under the Cardiovascular advisory committee, with regulatory classification as a Class III device under 21 CFR 870.3700. No sterility or single-use specifications are noted in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860546 | Date23 Apr 1986 | 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- Withdrawn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
- KRG
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What types of pacemaker systems can the Dialog Programmer 700 be used to program and configure?
The Dialog Programmer 700 is designed specifically for programming and configuring implantable pacemaker systems. It allows adjustments to pacing parameters such as heart rate, output, and timing to support patients with pacemaker-dependent arrhythmias or conduction disorders. It is intended for use with pacemakers classified under product code KRG, ensuring compatibility with a range of implantable cardiac devices.
Is the Dialog Programmer 700 intended for single-use or reusable applications in clinical settings?
The Dialog Programmer 700 is supplied as a reusable electronic system. It requires proper calibration and maintenance as outlined by the manufacturer to ensure accurate and reliable performance in clinical settings. There are no sterility specifications mentioned, so it is not intended for single-use.
Who is authorized to use the Dialog Programmer 700, and what kind of training is required?
The Dialog Programmer 700 is intended for use by trained healthcare professionals, specifically cardiologists and electrophysiologists. Since it involves programming implantable pacemakers, it requires specialized knowledge to ensure proper adjustments to pacing parameters and patient safety. The manufacturer’s guidelines should be followed for training and operational procedures.
What regulatory pathway was followed for the FDA clearance of the Dialog Programmer 700?
The Dialog Programmer 700 holds an FDA 510(k) clearance (K860546) under the Cardiovascular advisory committee. It was classified as a Class III device under 21 CFR 870.3700 and was determined to be substantially equivalent to a predicate device through a traditional review process. This classification reflects its role in critical cardiac rhythm management.
Are there specific storage requirements for the Dialog Programmer 700, given its reusable nature?
While the provided data does not specify detailed storage conditions, the Dialog Programmer 700 is a reusable electronic device that requires proper maintenance and calibration. It should be stored in a clean, controlled environment to prevent damage or interference with its functionality. Adherence to the manufacturer’s operational guidelines is essential to ensure longevity and reliability.