# K063042: Cardiomem CM 3000-12BT

- Pathway: 510(k) (Special)
- Applicant: Getemed Medizin- Und Informationstechnik AG
- Decided: May 30, 2007 after 239 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: 3 generations back to K942704 (1994). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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). Our OCR of the scanned summary read K052558, FDA’s number for VCS, Model S4T (Cycling and Health Tech. Industry R&D Center/Chc). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CE-TO00DX-BT ECG Recorder/Transmitter”.

## Cited in the summary but kept off the family tree
- K081688: CardioMem CM 3000-12 Holter recorder. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K130785: SEER 1000 (2013), 0 descendants of its own
- K122272: Cardiomem (2013), 0 descendants of its own

## Indications for use
The CardioMem CM 3000-12BT is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath or those that need to be monitored to judge their current cardiac functionality.

Source page: https://510kreport.com/device/K063042
Methodology: https://510kreport.com/methodology