MEDILOG FD4
by Oxford Instruments Medical Systems 510(k)
Active
510(k) K970902
Overview
The MEDILOG FD4 is a Recorder, Magnetic Tape, Medical device classified under product code DSH and regulation number 870.2800. It is a Class 2 cardiovascular device designed for recording electrocardiographic data.
The device was cleared through the FDA 510(k) pathway under K970902 with a traditional clearance type and a substantially equivalent decision. It was manufactured by Oxford Instruments Medical Systems and received clearance on May 5, 1997, following a submission received on March 11, 1997.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970902 | Date5 May 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DSH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Oxford Instruments Medical Systems
Questions
What is the primary use of the MEDILOG FD4 in clinical settings?
The MEDILOG FD4 is designed specifically for recording electrocardiographic (ECG) data. It is a Class 2 cardiovascular device used to capture and store heart rhythm information for diagnostic purposes, helping clinicians analyze cardiac activity.
How was the MEDILOG FD4 approved by the FDA, and what does that mean for its regulatory status?
The MEDILOG FD4 was cleared through the FDA’s 510(k) pathway under the reference number K970902, with a decision of ‘Substantially Equivalent’ to a predicate device. This means the FDA determined it met the same performance standards as an existing approved device, ensuring its safety and effectiveness for recording ECG data as intended.
Is the MEDILOG FD4 a single-use or reusable device, and what does that imply for its maintenance?
The provided data does not specify whether the MEDILOG FD4 is single-use or reusable. However, as a magnetic tape recorder for ECG data, it is likely designed for repeated use in clinical settings, requiring proper calibration, cleaning, and maintenance to ensure accurate and reliable recordings over time.
What type of storage or handling requirements should be considered for the MEDILOG FD4?
While the data does not detail specific storage conditions, magnetic tape recorders like the MEDILOG FD4 typically require protection from extreme temperatures, humidity, and magnetic interference. Proper storage in a dry, controlled environment and handling with care to avoid physical damage or exposure to electromagnetic fields are recommended to preserve data integrity.