Automated Non-Invasive Pressure Module
by Gould, Inc.
510(k) K840909
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840909 | Date15 Jun 1984 | 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- Withdrawn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, 22 Sep 2026
An automated non-invasive pressure module is a cardiovascular device designed to measure blood pressure without penetrating the skin. It functions as a physiological monitoring tool that automatically acquires and processes arterial pressure data through external sensors.
This module is supplied as a reusable component intended for use in clinical settings such as hospitals or outpatient facilities. It is not sterile and requires cleaning between uses. The device received FDA 510(k) clearance (K840909) on June 15, 1984, and is classified under product code DXN with cardiovascular advisory committee review. No specifications regarding MRI safety, sizes, or storage conditions are provided in the data.
Other devices from Gould, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Automated Non-Invasive Pressure Module used for?
It is designed to measure blood pressure without penetrating the skin by automatically acquiring and processing arterial pressure data through external sensors, serving as a physiological monitoring tool in cardiovascular assessment.
Is the Automated Non-Invasive Pressure Module sterile or single-use?
The device is supplied as a reusable component and is not sterile; it requires cleaning between uses in clinical settings such as hospitals or outpatient facilities to maintain safe operation.
How was the Automated Non-Invasive Pressure Module regulated for market entry?
It received FDA 510(k) clearance under submission K840909 on June 15, 1984, following a traditional review process with cardiovascular advisory committee evaluation, and was found substantially equivalent to a predicate device.