# K974351: Biolog 3000 Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical, Inc.
- Decided: Apr 1, 1998 after 133 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAX 1 Exercise Testing System: named in the summary without a submission number

## Most influential descendants
- K030535: Ekgcard System (2003), 5 descendants of its own
- K050674: Physioglove ES (2006), 2 descendants of its own
- K103791: Physioglove ES with Ecg Analysis (2011), 1 descendant of its own
- K103427: Mobileecg System (2011), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000 unit, a User’s Manual, and accessories. Additional device description information is presented in = i iption.

Source page: https://510kreport.com/device/K974351
Methodology: https://510kreport.com/methodology