Deluxe Adjustable Height Ultrasound Table
FDA 510(k) K922604 · Biodan Medical Systems, Ltd.
510(k) numberK922604
Submission
- Device name
- Deluxe Adjustable Height Ultrasound Table
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- June 2, 1992
- Decision date
- October 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Deluxe Adjustable Height Ultrasound Table cleared by the FDA?
Deluxe Adjustable Height Ultrasound Table (K922604) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 140 days after the submission was received.
What is the product code of K922604?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.