Hommed Sentry IIIB-F Patient Monitor System
by Hommed, LLC
510(k) K040651
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040651 | Date10 Aug 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- Withdrawn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, 21 Sep 2026
The Hommed Sentry IIIB-F Patient Monitor System is a device designed for measuring and displaying patient physiological functions including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. It is intended for use in home and healthcare facility applications under physician orders to allow retrospective review of certain patient vital signs.
The system is available with physicians' orders only and can be used by patients in home settings or by healthcare providers in clinical environments. The device is supplied as a complete system and is authorized under FDA 510(k) K040651 with product code DXN. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the data.
Other devices from Hommed, LLC
Questions
AI-generated answers, 21 Sep 2026
What is the Hommed Sentry IIIB-F Patient Monitor System used for?
The Hommed Sentry IIIB-F Patient Monitor System is designed for measuring and displaying patient physiological functions including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. It is intended for use in home and healthcare facility applications under physician orders to allow retrospective review of certain patient vital signs.
How is the Hommed Sentry IIIB-F Patient Monitor System supplied?
The device is supplied as a complete system and is available with physicians' orders only. It can be used by patients in home settings or by healthcare providers in clinical environments. The system is authorized under FDA 510(k) K040651 with product code DXN.
Is the Hommed Sentry IIIB-F Patient Monitor System sterile or single-use?
No information regarding sterility, single-use or reusable status is provided in the device data. The product is supplied as a complete system, but specific details about sterility or whether it's designed for single-use or multiple uses are not included in the available information.
What are the regulatory approvals for the Hommed Sentry IIIB-F Patient Monitor System?
The Hommed Sentry IIIB-F Patient Monitor System is authorized under FDA 510(k) K040651 with product code DXN. It received a traditional clearance with a decision code of SESE (Substantially Equivalent) on 2004-08-10, and was reviewed by the Cardiovascular advisory committee.