The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Nuclear Patient Sanning Tables, Various Types.
| Device ID | K926083 |
| 510k Number | K926083 |
| Device Name: | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES |
| Classification | Camera, Scintillation (gamma) |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-02-12 |