Ers System
FDA 510(k) K863286 · General Electric Co.
510(k) numberK863286
Submission
- Device name
- Ers System
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- August 25, 1986
- Decision date
- October 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ers System cleared by the FDA?
Ers System (K863286) received a 510(k) decision of Substantially Equivalent on October 27, 1986, 63 days after the submission was received.
What is the product code of K863286?
The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.