# K013615: Micro-Induction 1000 System

- Pathway: 510(k) (Traditional)
- Applicant: Harbinger Medical, Inc.
- Decided: May 29, 2002 after 205 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: 3 generations back to K930806 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950018: Cambridge Heart CH 2000 Stress Test System, Cambridge Heart, Inc. (1996) Summary page 1.
- K983102: Cardiac Diagnostic System Model CH 2000, Cambridge Heart, Inc. (1999) Summary page 2.
- K001034: Model Aps Alternans Processing System, Cambridge Heart, Inc. (2000) Summary page 1.
- K002230: Cambridge Heart Micro-V Alternans Sensor, Model 20327-002, Cambridge Heart, Inc. (2000) Summary page 2.
- K962115: Cambridge Heart HI-Res Ecg Electrode, Cambridge Heart, Inc. (1996) Summary page 1.
- K955015: Zymed Holter Scanner Model 2010, Zymed Medical Instrumentation (1996) Summary page 1.

## Most influential descendants
- K090249: Modification to: Micro-Induction 1000 System (2009), 0 descendants of its own

## Indications for use
The MI-1000 is used to measure Wavelet Surface Residanm indices at rest and during low level electrical stimalation during the cardiac refractory periad. This data is peescated in 2 erapbical format far interpretation by 2 trained phiysician. The MI-1000 is akso used for the measurement of SAEOG indices. The MI-1000 should be used anly as & adjunct to clinical Iistory and fhe results of adber noaInvasive andfor Invasive tesés.

Source page: https://510kreport.com/device/K013615
Methodology: https://510kreport.com/methodology