The following data is part of a premarket notification filed by U.s. Imaging Tables, Inc. with the FDA for Electrophysiology Tilt Table Model #9660.
| Device ID | K965105 |
| 510k Number | K965105 |
| Device Name: | ELECTROPHYSIOLOGY TILT TABLE MODEL #9660 |
| Classification | Table, Radiographic, Tilting |
| Applicant | U.S. IMAGING TABLES, INC. 28 CENTRAL AVE. Happauge, NY 11788 |
| Contact | Ronald Denezzo |
| Correspondent | Ronald Denezzo U.S. IMAGING TABLES, INC. 28 CENTRAL AVE. Happauge, NY 11788 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-01-30 |
| Summary: | summary |