# K233266: Mediblu Ecg System

- Pathway: 510(k) (Traditional)
- Applicant: Mediblu Medical, LLC
- Decided: Jun 12, 2024 after 257 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: 9 generations back to K921669 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123816: Digital Electrocardiographs, Shenzhen Biocare Electronics Co., Ltd. (2013) Summary page 4.
- K132758: Digital Electrocardiograph, Shenzhen Biocare Bio-Medical Equipment Co., Ltd. (2014) Summary page 5.
- K160092: Digital Electrocardiograph, Shenzhen Biocare Bio-Medical Equipment Co., Ltd. (2016) Summary page 5.
- K122712: Digital Electrocardiograph, Shenzhen Biocare Electronics Co., Ltd. (2012) Summary page 5.

## Indications for use
The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K233266
Methodology: https://510kreport.com/methodology