B.D.A.S.
FDA 510(k) K813065 · General Electric Co.
510(k) numberK813065
Submission
- Device name
- B.D.A.S.
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 30, 1981
- Decision date
- December 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was B.D.A.S. cleared by the FDA?
B.D.A.S. (K813065) received a 510(k) decision of Substantially Equivalent on December 8, 1981, 39 days after the submission was received.
What is the product code of K813065?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.