Identifiers
- 510(k) Number
- K073146 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)
PADNET+ is a plethysmograph device that operates using photoelectric, pneumatic or hydraulic technology. It is designed for cardiovascular applications and is classified as a Class II medical device.
The device is manufactured by Biomedix, Inc. and received FDA 510(k) clearance with decision code SESE on November 21, 2007. It is supplied with multiple registration numbers and is regulated under product code JOM. The device is intended for use in cardiovascular settings and is not specified as single-use or reusable in the provided data.
Frequently asked questions
What is the PADNET+ device used for?
PADNET+ is a plethysmograph device designed for cardiovascular applications. It operates using photoelectric, pneumatic or hydraulic technology to assist in cardiovascular assessments and monitoring.
Is the PADNET+ device single-use or reusable?
The provided data does not specify whether the PADNET+ device is single-use or reusable. The device is manufactured by Biomedix, Inc. and is classified as a Class II medical device for cardiovascular use.
What regulatory approvals does the PADNET+ have?
PADNET+ received FDA 510(k) clearance with decision code SESE on November 21, 2007. It is regulated under product code JOM and is classified as a Class II medical device for cardiovascular applications.
How is the PADNET+ device supplied?
The PADNET+ device is supplied with multiple registration numbers as indicated in the regulatory data. The device is manufactured by Biomedix, Inc. and is intended for use in cardiovascular settings.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073146 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedix-Inc
- FDA Applicant
- Biomedix, Inc.
Sources (1)
- FDA 510(k) K073146 24 fields · synced Oct 6, 2026