Vivosonic
FDA 510(k) K984562 · Sonotech, Inc.
510(k) numberK984562
Submission
- Device name
- Vivosonic
- Applicant
- Sonotech, Inc.
Bellingham, WA, US - Received
- December 23, 1998
- Decision date
- June 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K013701 | Endo-GlideGCJ · Traditional | 02/04/2002SE |
| K013170 | Scantac Membrane or Scantac StripITX · Traditional | 11/13/2001SE |
| K983691 | Scanflex Solid Couplant MembraneITX · Traditional | 05/05/1999SE |
| K983985 | Hybrisonic SheathITX · Traditional | 02/25/1999SE |
| K981028 | Ultra Image and Ultra ScanITX · Traditional | 08/21/1998SE |
| K964658 | OasisITX · Traditional | 02/14/1997SE |
Questions and answers
When was Vivosonic cleared by the FDA?
Vivosonic (K984562) received a 510(k) decision of Substantially Equivalent on June 8, 1999, 167 days after the submission was received.
What is the product code of K984562?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.