Ultramix
FDA 510(k) K962093 · Sonotech, Inc.
510(k) numberK962093
Submission
- Device name
- Ultramix
- Applicant
- Sonotech, Inc.
Bellingham, WA, US - Received
- May 29, 1996
- Decision date
- December 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ultramix cleared by the FDA?
Ultramix (K962093) received a 510(k) decision of Substantially Equivalent on December 23, 1996, 208 days after the submission was received.
What is the product code of K962093?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.