Digitilt LS-30 Remote Control
FDA 510(k) K834288 · Elscint, Inc.
510(k) numberK834288
Submission
- Device name
- Digitilt LS-30 Remote Control
- Applicant
- Elscint, Inc.
Walker, MI, US - Received
- November 28, 1983
- Decision date
- December 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Digitilt LS-30 Remote Control cleared by the FDA?
Digitilt LS-30 Remote Control (K834288) received a 510(k) decision of Substantially Equivalent on December 29, 1983, 31 days after the submission was received.
What is the product code of K834288?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.