# K090493: Signal

- Pathway: 510(k) (Traditional)
- Applicant: Zargis Medical Corp.
- Decided: Aug 7, 2009 after 163 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K771653 (1977). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990809: Cadiscope Electronic Stethoscope, Caditec AG (1999) Summary page 1.
- K001788: Estation Electronic Stethoscope, Model DR200, Erecords Enterprises (2000) Summary page 1.
- K013725: Meditron II Thesterthoscope System, Meditron AS (2002) Summary page 1.

## Most influential descendants
- K100531: Viscope, Model 100P,100S (2010), 0 descendants of its own

## Indications for use
Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.

Source page: https://510kreport.com/device/K090493
Methodology: https://510kreport.com/methodology