Treatment Table, Model #825-100
FDA 510(k) K930262 · Biodan Medical Systems, Ltd.
510(k) numberK930262
Submission
- Device name
- Treatment Table, Model #825-100
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- January 19, 1993
- Decision date
- March 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INO – Chair, Positioning, Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3110
- Specialty
- Physical Medicine
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|---|---|---|
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| K930259 | Traction Table Model #825-200JFB · Traditional | 03/24/1993SE |
| 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 |
| K922591 | Urological C-Arm Table, Model #056-450IXR · Traditional | 11/27/1992SE |
| 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 |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | 07/13/1992SE |
Questions and answers
When was Treatment Table, Model #825-100 cleared by the FDA?
Treatment Table, Model #825-100 (K930262) received a 510(k) decision of Substantially Equivalent on March 29, 1993, 69 days after the submission was received.
What is the product code of K930262?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.