L/U Arm-Vascular
FDA 510(k) K781571 · General Electric Co.
510(k) numberK781571
Submission
- Device name
- L/U Arm-Vascular
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- September 14, 1978
- Decision date
- November 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was L/U Arm-Vascular cleared by the FDA?
L/U Arm-Vascular (K781571) received a 510(k) decision of Substantially Equivalent on November 27, 1978, 74 days after the submission was received.
What is the product code of K781571?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.