Multiscriptor EK Various #43
510(k) K832015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832015 | Date31 Oct 1983 | 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- Withdrawn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 Multiscriptor EK Various #43 is a Cardiovascular Device designed for electrocardiogram (ECG) recording and analysis. It captures and displays electrical activity of the heart, enabling clinicians to evaluate cardiac rhythm, identify arrhythmias, and assess myocardial function. As a substantially equivalent device under FDA classification DPS, it serves as a diagnostic tool for monitoring cardiac health in clinical and ambulatory settings.
This device is supplied as a reusable medical instrument, intended for use in hospital or clinical environments where ECG monitoring is required. It operates in non-MRI environments and is regulated under FDA 510(k) clearance (K832015), with a traditional review process through the Cardiovascular (CV) advisory committee. Storage and handling follow standard medical device protocols for reusable diagnostic equipment, ensuring proper calibration and maintenance for accurate cardiac recordings.
Other devices from Litton Medical Electronics
Questions
AI-generated answers, 1 Oct 2026
What is the Multiscriptor EK Various #43 used for?
The Multiscriptor EK Various #43 is designed specifically for electrocardiogram (ECG) recording and analysis. It captures and displays the heart’s electrical activity, allowing clinicians to evaluate cardiac rhythm, detect arrhythmias, and assess myocardial function. This makes it essential for diagnosing and monitoring cardiac health in both clinical and ambulatory environments where precise ECG data is required.
Is the Multiscriptor EK Various #43 a single-use or reusable device?
This device is supplied as a reusable medical instrument. It is intended for repeated use in hospital or clinical settings where ECG monitoring is a routine requirement. Proper calibration and maintenance are necessary to ensure consistent accuracy and reliability over multiple uses.
What regulatory clearance does the Multiscriptor EK Various #43 hold?
The device holds FDA 510(k) clearance under the reference number K832015. It was classified under the product code DPS (Diagnostic, Cardiovascular, Electrocardiograph) and was reviewed through the Cardiovascular (CV) advisory committee using a traditional review process. This clearance confirms its substantial equivalence to a predicate device.
How should the Multiscriptor EK Various #43 be stored and handled?
Storage and handling follow standard protocols for reusable diagnostic equipment. The device must be stored in a clean, controlled environment to prevent contamination or damage. Regular calibration and maintenance are required to ensure accurate ECG recordings. Adherence to manufacturer guidelines for cleaning and servicing is critical for optimal performance and compliance with medical device regulations.
Can the Multiscriptor EK Various #43 be used in MRI environments?
No, the Multiscriptor EK Various #43 is explicitly designed for use in non-MRI environments. Magnetic resonance imaging (MRI) environments involve strong magnetic fields and radiofrequency interference that could compromise the device’s functionality or safety. Always verify the environment’s compatibility with the device specifications before use.