The following data is part of a premarket notification filed by Radiological Engineering, Inc. with the FDA for Rei-38 Radiographic Table.
Device ID | K873702 |
510k Number | K873702 |
Device Name: | REI-38 RADIOGRAPHIC TABLE |
Classification | Table, Radiographic, Stationary Top |
Applicant | RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
Contact | Lee B Moulton |
Correspondent | Lee B Moulton RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1988-04-22 |