Bone Mineral Densitometry Option B7918AA
FDA 510(k) K863618 · General Electric Co.
510(k) numberK863618
Submission
- Device name
- Bone Mineral Densitometry Option B7918AA
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- September 16, 1986
- Decision date
- March 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Bone Mineral Densitometry Option B7918AA cleared by the FDA?
Bone Mineral Densitometry Option B7918AA (K863618) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 174 days after the submission was received.
What is the product code of K863618?
The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.