# K051450: Extended Measurements System

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Nov 10, 2005 after 161 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 K920626 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043074: Liberty System, Inovise Medical, Inc. (2005) Summary page 2.

## Most influential descendants
- K070136: Audicor 200 System, Models 200D and 200S (2007), 0 descendants of its own

## Indications for use
The Extended Measurements System, when used with Audicor Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition, the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data. The Extended Measurements System can be used as an add-on device to work in conjunction with an Audicor-enabled device, or as a stand-alone electrocardiograph. The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician, and is for use on adults (> 18 years).

Source page: https://510kreport.com/device/K051450
Methodology: https://510kreport.com/methodology