SDU-500 Diagnostic Ultrasound Instrument
FDA 510(k) K875187 · Shimadzu Corp.
510(k) numberK875187
Submission
- Device name
- SDU-500 Diagnostic Ultrasound Instrument
- Applicant
- Shimadzu Corp.
Kyoto City 604 Japan, JP - Received
- December 22, 1987
- Decision date
- December 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was SDU-500 Diagnostic Ultrasound Instrument cleared by the FDA?
SDU-500 Diagnostic Ultrasound Instrument (K875187) received a 510(k) decision of Substantially Equivalent on December 12, 1988, 356 days after the submission was received.
What is the product code of K875187?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.