Bp-Tel Trans-Telephonic Blood Pressure Measurement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K983717 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM is a non-invasive blood pressure measurement system classified under product code DXN. It is designed to measure blood pressure and transmit the data via telephone to a central station for storage and review.
The system includes a patient unit for home use and a central computer program intended for use on a personal computer to receive, store, and manage blood pressure data. It was cleared through the FDA 510(k) process under K983717, with a decision date of September 16, 1999, and is classified as a Class II device with special controls.
Frequently asked questions
What is the BP-TEL Trans-Telephonic Blood Pressure Measurement System used for?
The BP-TEL system is designed to measure blood pressure non-invasively and transmit the measurement data via telephone to a central station where it can be stored, reviewed, and managed by healthcare providers.
How is the BP-TEL system supplied and what components does it include?
The system includes a patient unit intended for home use and a central computer program designed to run on a personal computer to receive, store, and manage blood pressure data transmitted from the patient unit.
Is the BP-TEL system intended for single-use or repeated use?
The BP-TEL system is designed for repeated use; the patient unit is intended for ongoing home blood pressure monitoring, and the central software supports long-term data storage and review.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bp-tel Trans-telephonic Blood Pressure Measurement System (K983717 ..., K983717 FDA 510(k) - BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE ..., Bp-tel Trans-telephonic Blood Pressure Measurement System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983717 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aerotel Medical Systems (1998) Ltd.
- FDA Applicant
- Aerotel Medical Systems (1998) , Ltd.
Sources (1)
- FDA 510(k) K983717 24 fields · synced Sep 22, 2026