Acuson S228 and S328 Transducers for Abdom. Appli.
FDA 510(k) K874363 · Acuson Computed Sonography
510(k) numberK874363
Submission
- Device name
- Acuson S228 and S328 Transducers for Abdom. Appli.
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- October 23, 1987
- Decision date
- May 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Acuson S228 and S328 Transducers for Abdom. Appli. cleared by the FDA?
Acuson S228 and S328 Transducers for Abdom. Appli. (K874363) received a 510(k) decision of Substantially Equivalent on May 2, 1988, 192 days after the submission was received.
What is the product code of K874363?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.