Pocket Transmitter PT-10
by Eldeco
510(k) K761073
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761073 | Date28 Dec 1976 | 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- Withdrawn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, 1 Oct 2026
The Pocket Transmitter PT-10 is a handheld electrocardiograph transmitter and receiver device designed for cardiovascular applications. Classified under Transmitters and Receivers, it facilitates wireless transmission of electrocardiogram (ECG) signals, enabling remote monitoring and telemetry in clinical settings. Its compact form factor allows for portability while maintaining functionality for real-time cardiac data acquisition.
This device is supplied as a reusable medical instrument, intended for use in clinical environments where wireless ECG transmission is required. It operates within the regulatory framework of FDA 510(k) clearance (K761073) under classification DXH, adhering to the standards outlined in regulation 870.2920. The PT-10 is not specified as MRI-safe or single-use, and its storage conditions are not detailed in the provided data. Authorized for cardiovascular applications, it is intended for use in settings where wireless ECG transmission is necessary for patient monitoring.
Other devices from Eldeco
Questions
AI-generated answers, 1 Oct 2026
What is the Eldeco PT-10 Pocket Transmitter used for?
The Eldeco PT-10 is designed for cardiovascular applications, specifically to facilitate wireless transmission of electrocardiogram (ECG) signals. Its primary purpose is to enable remote monitoring and telemetry of cardiac data in clinical environments, allowing healthcare providers to observe real-time ECG readings without physical connection to the patient.
Is the PT-10 a single-use or reusable device?
The PT-10 is supplied as a reusable medical instrument. This classification allows for repeated use in clinical settings, provided proper cleaning, maintenance, and sterilization protocols are followed between patients to ensure safety and functionality.
What regulatory approval does the PT-10 hold?
The Eldeco PT-10 has received FDA 510(k) clearance under the classification code DXH, with the clearance number K761073. This approval indicates that the device is deemed substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 870.2920.
How is the PT-10 supplied, and what are its key features?
The PT-10 is supplied as a standalone handheld device combining transmitter and receiver functionality. Its compact form factor ensures portability, making it suitable for use in various clinical environments where wireless ECG transmission is required. The device is intended for real-time cardiac data acquisition and remote monitoring.
Are there any specific storage instructions for the PT-10?
The provided data does not specify detailed storage conditions for the PT-10. However, as a reusable medical device, it should be stored in a clean, dry environment, protected from physical damage and contamination. Follow manufacturer guidelines for optimal longevity and functionality.