Advanced Diagnostic Viewer (Adv)
FDA 510(k) K963697 · Bio-Vascular, Inc.
510(k) numberK963697
Submission
- Device name
- Advanced Diagnostic Viewer (Adv)
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- September 16, 1996
- Decision date
- November 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Advanced Diagnostic Viewer (Adv) cleared by the FDA?
Advanced Diagnostic Viewer (Adv) (K963697) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 72 days after the submission was received.
What is the product code of K963697?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.