Model 656 Arrhythmia Analyzer
510(k) K792080
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792080 | Date4 Dec 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1435
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Model 656 Arrhythmia Analyzer is a computer, diagnostic, pre-programmed, single-function device. It is classified as a Class II device with special controls, and its primary medical specialty is cardiovascular. The device is substantially equivalent to other devices on the market.
The Model 656 Arrhythmia Analyzer is supplied by Del Mar Avionics and has been assigned the product code DXG and regulation number 870.1435. It was cleared by the FDA on December 4, 1979, with the k number K792080, indicating that it is substantially equivalent to other devices. The device is intended for diagnostic use in a cardiovascular setting.
Other devices from Del Mar Avionics
Questions
AI-generated answers, 22 Sep 2026
What is the Model 656 Arrhythmia Analyzer used for?
The Model 656 Arrhythmia Analyzer is used for diagnostic purposes in a cardiovascular setting, providing analysis of arrhythmias.
Is the Model 656 Arrhythmia Analyzer a single-use device?
The device description does not specify if it is single-use or reusable, but it is a pre-programmed, single-function device.
What is the regulatory classification of the Model 656 Arrhythmia Analyzer?
The Model 656 Arrhythmia Analyzer is classified as a Class II device with special controls, and has been assigned the product code DXG and regulation number 870.1435.
When was the Model 656 Arrhythmia Analyzer cleared by the FDA?
The Model 656 Arrhythmia Analyzer was cleared by the FDA on December 4, 1979, with the k number K792080, indicating substantial equivalence to other devices.