The following data is part of a premarket notification filed by Rms Div. with the FDA for Elite 1500 Radiographic Tilting Table.
Device ID | K896324 |
510k Number | K896324 |
Device Name: | ELITE 1500 RADIOGRAPHIC TILTING TABLE |
Classification | Table, Radiographic, Tilting |
Applicant | RMS DIV. 2301 WINDSOR CT. Addison, IL 60101 |
Contact | William J Engel |
Correspondent | William J Engel RMS DIV. 2301 WINDSOR CT. Addison, IL 60101 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-01 |
Decision Date | 1989-11-21 |