# K070136: Audicor 200 System, Models 200D and 200S

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Apr 13, 2007 after 87 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K920626 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
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.
- K051450: Extended Measurements System, Inovise Medical, Inc. (2005) Summary page 2.

## Indications for use
The Audicor 200 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 report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data. 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/K070136
Methodology: https://510kreport.com/methodology