OMAR Magnetic Tape Recorder
by Oxford Medilog, Inc. 510(k)
Active
510(k) K830915
Overview
The OMAR is a Recorder, Magnetic Tape, Medical, designed for the digital recording and playback of cardiovascular signals. It captures and stores electrophysiological data, such as ECG or other cardiac waveforms, onto magnetic tape for later analysis or review.
This device is intended for use in clinical settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K830915) and is classified as a Class II device (regulation number 870.2800). The OMAR is not described as sterile or single-use, and no MRI safety information is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830915 | Date7 Jul 1983 | 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- Withdrawn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
- Full name
- Omar
- 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 Medilog, Inc.
Questions
What is the primary purpose of the OMAR device in a clinical setting?
The OMAR is designed specifically for recording and playback of cardiovascular signals, such as ECG or other cardiac waveforms. It captures these electrophysiological data onto magnetic tape, allowing clinicians to analyze or review the recordings later. This makes it useful for monitoring heart activity in real-time or for retrospective analysis.
Is the OMAR device intended for single-use or reusable applications?
The OMAR is explicitly described as a reusable medical instrument. It is not marketed or intended for single-use, meaning it can be cleaned, maintained, and used repeatedly in clinical settings.
How is the OMAR device regulated by the FDA, and what does that mean for its use?
The OMAR holds FDA 510(k) clearance under the classification of a Class II device (regulation number 870.2800). This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA safety and performance standards. Clinicians can rely on its regulatory status as a Class II device, which indicates it has undergone evaluation for its intended use in recording cardiovascular signals.
What type of storage or handling requirements should be considered for the OMAR device?
Since the OMAR is a reusable device, proper cleaning, maintenance, and storage protocols must be followed to ensure its reliability and longevity. While the data does not specify exact storage conditions, it is critical to follow manufacturer guidelines for handling magnetic tape and the recorder itself to prevent data corruption or mechanical failure. No sterility is implied, so standard disinfection procedures for reusable medical equipment should apply.
Does the OMAR device have any special considerations for use in environments with magnetic interference?
The OMAR relies on magnetic tape for recording and playback, so it is important to use it in environments where magnetic interference is minimized. While the data does not provide explicit MRI safety information, the presence of magnetic tape suggests that exposure to strong magnetic fields (such as those in MRI machines) could potentially affect its performance or data integrity. Clinicians should ensure the device is used in appropriate settings to avoid such interference.