Vivosonic Dianostic Ultrasound Imaging Coupling Media
FDA 510(k) K020956 · Microtek Medical, Inc.
510(k) numberK020956
Submission
- Device name
- Vivosonic Dianostic Ultrasound Imaging Coupling Media
- Applicant
- Microtek Medical, Inc.
Columbus, MS, US - Received
- March 25, 2002
- Decision date
- May 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vivosonic Dianostic Ultrasound Imaging Coupling Media cleared by the FDA?
Vivosonic Dianostic Ultrasound Imaging Coupling Media (K020956) received a 510(k) decision of Substantially Equivalent on May 16, 2002, 52 days after the submission was received.
What is the product code of K020956?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.