The following data is part of a premarket notification filed by Absolute X-ray Corp. with the FDA for Table,radiographic-fluoroscopic,tomographic,remote.
Device ID | K854486 |
510k Number | K854486 |
Device Name: | TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE |
Classification | Table, Radiographic, Tilting |
Applicant | ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
Contact | George S Pavel |
Correspondent | George S Pavel ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City, NY 11106 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-07 |
Decision Date | 1986-01-10 |