← Back to catalogue

Tesla NIBP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062974

by Mammendorfer Institut Fur Physik Und Medizin GmbH

Identifiers

510(k) Number
K062974 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 Tesla NIBP is a non-invasive blood pressure monitor designed for accurate measurement of systolic and diastolic blood pressure. It employs oscillometric technology to provide reliable readings, suitable for clinical environments where continuous or periodic monitoring is required. This device is classified under the product code DXN, indicating its use in cardiovascular assessments and patient monitoring.

The Tesla NIBP is intended for use in clinical settings, including MRI-compatible environments, where precise blood pressure measurements are essential. Supplied as a reusable device, it adheres to FDA clearance under 510(k) number K062974, with a traditional review pathway through the Cardiovascular (CV) advisory committee. The device is not single-use and requires proper calibration and maintenance to ensure accuracy. No specific sterility standards are mentioned, but it must comply with relevant regulatory guidelines for reusable medical devices.

Frequently asked questions

What is the Tesla NIBP designed for and where can it be used?

The Tesla NIBP is an oscillometric non-invasive blood pressure (NIBP) monitor specifically designed for accurate measurement of systolic and diastolic blood pressure. It is intended for clinical environments where precise cardiovascular assessments are required, including MRI-compatible settings. The device leverages oscillometric technology to ensure reliable readings, making it suitable for continuous or periodic patient monitoring in hospitals, clinics, or other healthcare facilities.

Is the Tesla NIBP a single-use or reusable device?

The Tesla NIBP is a reusable device. Unlike single-use monitors, it is built for repeated clinical use with proper calibration and maintenance to ensure ongoing accuracy. This design aligns with its FDA clearance under the 510(k) pathway, where durability and reusability are key considerations for cardiovascular monitoring equipment.

What regulatory pathway was followed for the Tesla NIBP’s FDA clearance?

The Tesla NIBP received FDA clearance through the traditional review pathway under the 510(k) process, specifically reviewed by the Cardiovascular (CV) advisory committee. The clearance number is K062974, and the device was determined to be substantially equivalent to a predicate device. This pathway ensures compliance with regulatory standards for non-invasive blood pressure monitors used in clinical settings.

Does the Tesla NIBP require any special handling or sterility measures?

While the Tesla NIBP is not explicitly labeled as sterile, it must comply with all relevant regulatory guidelines for reusable medical devices to ensure patient safety. Proper cleaning, calibration, and maintenance protocols are essential to prevent contamination and maintain accuracy. Users should follow manufacturer guidelines for disinfection and upkeep to support its reliable performance in clinical environments.

What distinguishes the Tesla NIBP from other oscillometric blood pressure monitors?

The Tesla NIBP is distinguished by its MRI-compatibility, making it uniquely suitable for use in magnetic resonance imaging environments where traditional monitors may pose interference risks. Additionally, its oscillometric technology ensures high accuracy for both systolic and diastolic readings, catering to clinical settings requiring precise cardiovascular monitoring. The reusable design further sets it apart from single-use alternatives.

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: Tesla DUO - MRI patient Monitor | MIPM Mammendorfer Institut für Physik ..., Tesla NIBP - MIPM Mammendorfer Institut für Physik und Medizin - PDF ..., Zum Wohle des Menschen, im Dienste der Medizin | MIPM Mammendorfer ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mammendorfer Institut Fur Physik Und Medizin GmbH

Sources (1)

  • FDA 510(k) K062974 24 fields · synced Oct 6, 2026