Ud 2000 Video Option
FDA 510(k) K915342 · Diagnostic Ultrasound Corp.
510(k) numberK915342
Submission
- Device name
- Ud 2000 Video Option
- Applicant
- Diagnostic Ultrasound Corp.
Kirkland, WA, US - Received
- November 26, 1991
- Decision date
- June 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ud 2000 Video Option cleared by the FDA?
Ud 2000 Video Option (K915342) received a 510(k) decision of Substantially Equivalent on June 10, 1992, 197 days after the submission was received.
What is the product code of K915342?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.