Spot-Film Device 8835
FDA 510(k) K842184 · General Electric Co.
510(k) numberK842184
Submission
- Device name
- Spot-Film Device 8835
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- June 1, 1984
- Decision date
- July 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Spot-Film Device 8835 cleared by the FDA?
Spot-Film Device 8835 (K842184) received a 510(k) decision of Substantially Equivalent on July 17, 1984, 46 days after the submission was received.
What is the product code of K842184?
The FDA product code is IXL – Device, Spot-Film, a Class II (moderate risk) device regulated under 21 CFR 892.1670.