Cardiophonics 1000 Memory Monitor
510(k) K992772
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992772 | Date17 Sep 1999 | 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- Withdrawn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
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cardiophonics 1000 Memory Monitor is a Transmitter and Receiver, Electrocardiograph, Telephone (OpenFDA classification: DXH), designed to record and transmit electrocardiogram (ECG) data. It functions as a portable device capable of capturing cardiac electrical activity and storing it for later retrieval or remote transmission, facilitating cardiac monitoring in clinical or home settings.
This device is intended for single-use or reusable applications in cardiovascular monitoring, supplied as a Class II medical device under FDA 510(k) clearance (K992772) via the Special 510(k) pathway. It operates in non-sterile environments and is not MRI-compatible. The device is regulated under FDA regulation number 870.2920, with no third-party involvement in its distribution. Storage and handling follow standard medical device protocols as outlined in its specifications.
Other devices from Rlt Medical Assoc., Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Cardiophonics 1000 Memory Monitor in clinical settings?
The Cardiophonics 1000 Memory Monitor is designed to record and store electrocardiogram (ECG) data, allowing for portable cardiac monitoring. It captures cardiac electrical activity and can either store the data locally for later retrieval or transmit it remotely, making it useful for both clinical and home monitoring environments.
Is the Cardiophonics 1000 Memory Monitor intended for single-use or reusable applications?
The device is explicitly labeled for single-use or reusable applications, meaning it can be used multiple times if properly cleaned and maintained according to manufacturer guidelines. This flexibility accommodates different clinical workflows.
How should the Cardiophonics 1000 Memory Monitor be stored, and is it sterile?
The device is not sterile and is intended for use in non-sterile environments. Storage and handling should follow standard medical device protocols as outlined in its specifications, ensuring proper maintenance and functionality without compromising sterility requirements.
What regulatory pathway was used for FDA clearance of the Cardiophonics 1000 Memory Monitor?
The Cardiophonics 1000 Memory Monitor received FDA clearance through the Special 510(k) pathway, specifically under the classification of Transmitters and Receivers, Electrocardiograph, Telephone (product code: DXH). It was determined to be substantially equivalent to a predicate device and is regulated under FDA regulation number 870.2920.
Can the Cardiophonics 1000 Memory Monitor be used in an MRI environment?
No, the device is explicitly labeled as not MRI-compatible, meaning it should not be used in or near MRI equipment due to potential interference or safety risks.