Model 835 Spot Film Device
FDA 510(k) K827858 · General Electric Co.
510(k) numberK827858
Submission
- Device name
- Model 835 Spot Film Device
- Applicant
- General Electric Co.
Schenectady, NY, US - Received
- August 9, 1982
- Decision date
- August 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Model 835 Spot Film Device cleared by the FDA?
Model 835 Spot Film Device (K827858) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 15 days after the submission was received.