Hybrisonic Sheath
FDA 510(k) K983985 · Sonotech, Inc.
510(k) numberK983985
Submission
- Device name
- Hybrisonic Sheath
- Applicant
- Sonotech, Inc.
Bellingham, WA, US - Received
- November 9, 1998
- Decision date
- February 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Hybrisonic Sheath cleared by the FDA?
Hybrisonic Sheath (K983985) received a 510(k) decision of Substantially Equivalent on February 25, 1999, 108 days after the submission was received.
What is the product code of K983985?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.