Sigma 7000-6000 Infusion Pumps
by Sigma
510(k) K830038
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830038 | Date26 Jan 1983 | 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- Withdrawn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
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Sigma 7000-6000 Infusion Pumps are medical devices designed for the administration of intravenous drugs and fluids. These systems may include features to detect fault conditions, such as air in the infusion line or blockages, and activate an alarm to alert users.
The device is regulated under FDA 510(k) clearance. It is intended for use in a general hospital setting to provide controlled delivery of intravenous medications and fluids.
Other devices from Sigma
Questions
AI-generated answers, 27 Sep 2026
What is the primary purpose of the Sigma 7000-6000 Infusion Pumps?
These devices are intended for use in general hospital settings to provide the controlled delivery of intravenous medications and fluids to patients.
Do the Sigma 7000-6000 Infusion Pumps include safety monitoring features?
Yes, these systems are equipped with features designed to detect specific fault conditions, such as blockages or air in the infusion line, and will activate an alarm to alert the user.
What is the regulatory status of these infusion pumps?
The Sigma 7000-6000 Infusion Pumps are regulated under FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.