Sonel 3000A
FDA 510(k) K833223 · Cgr Medical Corp.
510(k) numberK833223
Submission
- Device name
- Sonel 3000A
- Applicant
- Cgr Medical Corp.
Mchenry, IL, US - Received
- September 8, 1983
- Decision date
- May 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Sonel 3000A cleared by the FDA?
Sonel 3000A (K833223) received a 510(k) decision of Substantially Equivalent on May 9, 1984, 244 days after the submission was received.
What is the product code of K833223?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.