The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Ultra-pro Ultrasound Scanning Table Model #056-650.
| Device ID | K950981 |
| 510k Number | K950981 |
| Device Name: | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 |
| Classification | Table, Radiographic, Tilting |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODEX MEDICAL SYSTEMS, INC. BROOKHAVEN R & D PLAZA 20 RAMSEY RD., P.O. BOX 702 Shirley, NY 11967 -0702 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-04-03 |