The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Spectrum Mark I Special Procedures Table.
Device ID | K931563 |
510k Number | K931563 |
Device Name: | SPECTRUM MARK I SPECIAL PROCEDURES TABLE |
Classification | Table, Radiographic, Tilting |
Applicant | SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
Contact | Robert L Welsh |
Correspondent | Robert L Welsh SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-30 |
Decision Date | 1993-08-23 |