Biolog 3000 Electrocardiograph
510(k) K974351
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974351 | Date1 Apr 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Biolog 3000 Electrocardiograph is a medical device classified as an electrocardiograph (Device Type: DPS), designed to record and display electrocardiogram (ECG) signals. It captures cardiac electrical activity using either a single-lead patient cable or a 12-lead simultaneous cable, enabling comprehensive cardiac monitoring. The device supports both 6-lead and 12-lead ECG recording, providing flexibility for clinical assessments. Its primary function is to visualize heart rhythms for diagnostic evaluation.
The Biolog 3000 Electrocardiograph is intended for use in clinical settings, such as hospitals, emergency rooms, or physician offices, where cardiac monitoring is required. It operates with a sampling rate of 500Hz and a frequency response range of 0.05–175Hz, ensuring accurate ECG signal acquisition. The device is reusable and does not require sterilization between uses, as specified in its design. Authorized for commercial distribution in the United States under an FDA 510(k) clearance (K974351), it adheres to regulatory standards for electrocardiographic devices.
Other devices from Micro Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Biolog 3000 Electrocardiograph used for?
The Biolog 3000 Electrocardiograph is designed to record and display electrocardiogram (ECG) signals, capturing cardiac electrical activity for diagnostic evaluation. It supports both 6-lead and 12-lead ECG recording, enabling comprehensive monitoring of heart rhythms in clinical settings such as hospitals, emergency rooms, or physician offices.
How is the Biolog 3000 Electrocardiograph supplied and does it require sterilization?
The device is supplied as a reusable electrocardiograph and does not require sterilization between uses. Its design ensures safe, repeated use in clinical environments without the need for sterilization procedures, making it practical for ongoing patient monitoring.
What types of ECG leads does the Biolog 3000 support?
The Biolog 3000 Electrocardiograph supports both single-lead and 12-lead simultaneous ECG recording, providing flexibility for clinical assessments. It also offers 6-lead recording, allowing clinicians to choose the appropriate lead configuration based on their diagnostic needs.
What are the technical specifications for ECG signal acquisition?
The device operates with a high sampling rate of 500Hz and a frequency response range of 0.05–175Hz, ensuring precise and accurate acquisition of ECG signals. These specifications help clinicians obtain clear and reliable cardiac rhythm data for diagnosis.
Is the Biolog 3000 Electrocardiograph approved for use in the United States?
Yes, the Biolog 3000 Electrocardiograph is authorized for commercial distribution in the United States under an FDA 510(k) clearance (K974351). This clearance confirms that the device meets regulatory standards for electrocardiographic devices as determined by the FDA.