Multi-Dop S
FDA 510(k) K926363 · Dantec Medical, Inc.
510(k) numberK926363
Submission
- Device name
- Multi-Dop S
- Applicant
- Dantec Medical, Inc.
Washington, DC, US - Received
- December 21, 1992
- Decision date
- June 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Multi-Dop S cleared by the FDA?
Multi-Dop S (K926363) received a 510(k) decision of Substantially Equivalent on June 19, 1995, 910 days after the submission was received.
What is the product code of K926363?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.