Central Station, Version 3.3H
by Hommed, LLC
510(k) K040032
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040032 | Date27 Feb 2004 | 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- Withdrawn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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
Central Station, Version 3.3H is a system for measurement of blood pressure, non-invasive, as classified under product code DXN and regulation 870.1130. It is designed to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric patients over 12 years of age, including NIBP, pulse rate, SpO2, temperature, and weight.
The device includes an HL7 interface to transfer data from the HomMed Central Station to vendor systems and storage media. It was cleared through the FDA 510(k) process under submission K040032, with a decision of substantially equivalent on February 27, 2004. The device is supplied by Hommed, LLC and is intended for use in cardiovascular monitoring settings.
Other devices from Hommed, LLC
Questions
AI-generated answers, 27 Sep 2026
What is the Central Station, Version 3.3H used for?
The Central Station, Version 3.3H is designed to retrospectively receive, display, and store monitored physiological parameters such as non-invasive blood pressure, pulse rate, SpO2, temperature, and weight from adult and pediatric patients over 12 years of age in cardiovascular monitoring settings.
How does the Central Station, Version 3.3H transfer data to other systems?
The device includes an HL7 interface that enables the transfer of data from the HomMed Central Station to vendor systems and storage media, allowing integration with external healthcare information systems for data management and record keeping.
Is the Central Station, Version 3.3H intended for single-patient or multi-patient use?
The Central Station, Version 3.3H is intended for use in clinical environments where it can receive data from multiple adult and pediatric patients over 12 years of age, making it suitable for multi-patient monitoring in cardiovascular care settings.