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3D Vascular Recorder

FDA 510(k)

Class II (US FDA 510(k))

510(k) K883908

by D. E. Hokanson, Inc.

Identifiers

510(k) Number
K883908 FDA 510(k)
FDA Product Code
JOM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2780 FDA 510(k)
Regulation Number
870.2780 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 3D Vascular Recorder is a photoelectric, pneumatic, or hydraulic plethysmograph used for cardiovascular diagnostic applications. It is designed to measure and record vascular physiological parameters.

This device is classified as a Class 2 medical device under regulation number 870.2780. It has received FDA 510(k) clearance under the traditional pathway, identified by reference number K883908.

Frequently asked questions

What is the primary function of the 3D Vascular Recorder?

The 3D Vascular Recorder is a plethysmograph designed to measure and record vascular physiological parameters for cardiovascular diagnostic applications.

What types of technology does this device utilize?

This device functions as a photoelectric, pneumatic, or hydraulic plethysmograph, allowing it to capture vascular data through these specific diagnostic modalities.

What is the regulatory status of this device?

The 3D Vascular Recorder is classified as a Class 2 medical device under regulation number 870.2780 and has received FDA 510(k) clearance under the traditional pathway, identified by reference number K883908.

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: K883908 FDA 510(k) - 3D VASCULAR RECORDER | D. E. Hokanson, Inc., Hokanson Vascular - Passionate About Vascular Health, 510(k) K883908 — 3D VASCULAR RECORDER - RegDataLab, 3D VASCULAR RECORDER 510 (k) K883908 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
D. E. Hokanson, Inc.

Sources (1)

  • FDA 510(k) K883908 24 fields · synced Sep 26, 2026