Urological C-Arm Table, Model #056-450
FDA 510(k) K922591 · Biodan Medical Systems, Ltd.
510(k) numberK922591
Submission
- Device name
- Urological C-Arm Table, Model #056-450
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- June 2, 1992
- Decision date
- November 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K926083 | Nuclear Patient Sanning Tables, Various TypesIYX · Traditional | 02/12/1993SE |
| K926082 | Cardiac Stress Table, 056-180/UNIV Roll Stress AttIZI · Traditional | 12/30/1992SE |
| K922605 | Trendelenburg Ultrasound Table, Model # 056-603IYO · Traditional | 10/20/1992SE |
| K922604 | Deluxe Adjustable Height Ultrasound TableIYO · Traditional | 10/20/1992SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | 07/23/1992SE |
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Questions and answers
When was Urological C-Arm Table, Model #056-450 cleared by the FDA?
Urological C-Arm Table, Model #056-450 (K922591) received a 510(k) decision of Substantially Equivalent on November 27, 1992, 178 days after the submission was received.
What is the product code of K922591?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.