Sdu 800 Diagnostic Ultrasound Instrument
FDA 510(k) K890913 · Shimadzu Precision Instruments, Inc.
510(k) numberK890913
Submission
- Device name
- Sdu 800 Diagnostic Ultrasound Instrument
- Applicant
- Shimadzu Precision Instruments, Inc.
Gardena, CA, US - Received
- February 24, 1989
- Decision date
- September 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Sdu 800 Diagnostic Ultrasound Instrument cleared by the FDA?
Sdu 800 Diagnostic Ultrasound Instrument (K890913) received a 510(k) decision of Substantially Equivalent on September 6, 1989, 194 days after the submission was received.
What is the product code of K890913?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.