# K082077: BT3/6, BT12

- Pathway: 510(k) (Traditional)
- Applicant: Corscience GmbH & Co. KG
- Decided: Sep 2, 2008 after 41 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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 K942704 (1994). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052556: CG-7000DX-BT Ecg Recorder/Transmitter, Card Guard Scientific Survival, Ltd. (2006) Summary page 2.

## Most influential descendants
- K110065: Spaulding IQ Electrocardiograph (2011), 2 descendants of its own
- K150564: Spaulding Electrocardiograph 2100iQ (2015), 1 descendant of its own
- K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb (2010), 1 descendant of its own
- K163607: ECG Acquisition Systems (2017), 0 descendants of its own
- K142352: CardiacLinx (2015), 0 descendants of its own

## Indications for use
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring device, such as a PC or hand-held device for display, review, printing, saving and post event processing by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.). Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.

Source page: https://510kreport.com/device/K082077
Methodology: https://510kreport.com/methodology