Electronic Gravity 300VC
by Ivent Corp.
510(k) K833953
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833953 | Date29 Dec 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- Withdrawn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
- LDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Electronic Gravity 300VC is a Controller, Infusion, Intravascular, Electronic device. It is classified as a Class II medical device under regulation number 880.5725.
The device received FDA 510(k) clearance under number K833953 on December 29, 1983, and is substantially equivalent to a predicate device. It is manufactured by Ivent Corp. and is intended for use in general hospital settings.
Other devices from Ivent Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Electronic Gravity 300VC used for?
The Electronic Gravity 300VC is an electronic controller designed for intravascular infusion therapy, intended to regulate fluid delivery in general hospital settings as part of intravenous therapy systems.
How is the Electronic Gravity 300VC supplied and is it reusable?
The device is supplied as a reusable electronic controller unit; it is not a disposable or single-use component and is intended for repeated use in clinical environments after appropriate cleaning and maintenance per manufacturer guidelines.
What regulatory pathway was used for the Electronic Gravity 300VC?
The Electronic Gravity 300VC received FDA 510(k) clearance under submission number K833953 on December 29, 1983, demonstrating substantial equivalence to a legally marketed predicate device under Class II regulations.