# K070014: Auto Detect for Telaheart DR200/E-a

- Pathway: 510(k) (Traditional)
- Applicant: North East Monitoring, Inc.
- Decided: May 25, 2007 after 142 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K923930 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061293: Telaheart Digital Recorder, North East Monitoring, Inc. (2006) Summary page 2.
- K033451: Heartrak Smart at/Heartrak SMART2, Universal Medical, Inc. (2004) Summary page 2.

## Indications for use
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode. Holter Mode Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation. Event Recorder The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation. The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.

Source page: https://510kreport.com/device/K070014
Methodology: https://510kreport.com/methodology