SDL-32 Electronic Linear Scanner
FDA 510(k) K850834 · Shimadzu Corp.
510(k) numberK850834
Submission
- Device name
- SDL-32 Electronic Linear Scanner
- Applicant
- Shimadzu Corp.
Gardena, CA, US - Received
- March 1, 1985
- Decision date
- October 31, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was SDL-32 Electronic Linear Scanner cleared by the FDA?
SDL-32 Electronic Linear Scanner (K850834) received a 510(k) decision of Substantially Equivalent on October 31, 1985, 244 days after the submission was received.
What is the product code of K850834?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.