The following data is part of a premarket notification filed by U.s. Imaging Tables, Inc. with the FDA for Fluoroview Series Fluoroscopic Tables.
Device ID | K965096 |
510k Number | K965096 |
Device Name: | FLUOROVIEW SERIES FLUOROSCOPIC TABLES |
Classification | Table, Radiographic, Tilting |
Applicant | U.S. IMAGING TABLES, INC. 28 CENTRAL AVE. Happauge, NY 11788 |
Contact | Robald Denezzo |
Correspondent | Robald 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 | 1997-01-27 |
Summary: | summary |