Electronic Gravity 300VC

FDA 510(k) K833953 · Ivent Corp.

Substantially Equivalent

510(k) numberK833953

Submission

Device name
Electronic Gravity 300VC
Applicant
Ivent Corp.
Walker, MI, US
Received
November 16, 1983
Decision date
December 29, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDR – Controller, Infusion, Intravascular, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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More from The Master Medical Corp.

510(k)DeviceDecision
K852259Ivent Intravenous Adminstration SetFPA · Traditional 06/07/1985SE
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Questions and answers

When was Electronic Gravity 300VC cleared by the FDA?

Electronic Gravity 300VC (K833953) received a 510(k) decision of Substantially Equivalent on December 29, 1983, 43 days after the submission was received.

What is the product code of K833953?

The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.