Diagnostic Ultrasound Transducer: PVE-582V
FDA 510(k) K891453 · Toshiba Medical Systems
510(k) numberK891453
Submission
- Device name
- Diagnostic Ultrasound Transducer: PVE-582V
- Applicant
- Toshiba Medical Systems
Tustin, CA, US - Received
- March 15, 1989
- Decision date
- June 1, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Diagnostic Ultrasound Transducer: PVE-582V cleared by the FDA?
Diagnostic Ultrasound Transducer: PVE-582V (K891453) received a 510(k) decision of Substantially Equivalent on June 1, 1989, 78 days after the submission was received.
What is the product code of K891453?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.