The following data is part of a premarket notification filed by Altairex Manufacturing, Inc. with the FDA for Altairex Bucky/cassette Tray Combination.
Device ID | K873849 |
510k Number | K873849 |
Device Name: | ALTAIREX BUCKY/CASSETTE TRAY COMBINATION |
Classification | Table, Radiographic, Stationary Top |
Applicant | ALTAIREX MANUFACTURING, INC. 1252 CHINOOK WAY Boulder, CO 80303 |
Contact | Aldona A Siczek,phd |
Correspondent | Aldona A Siczek,phd ALTAIREX MANUFACTURING, INC. 1252 CHINOOK WAY Boulder, CO 80303 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-10-28 |