The following data is part of a premarket notification filed by Kub Technologies, Inc with the FDA for Xpert 40 Specimen Radiography System.
Device ID | K071233 |
510k Number | K071233 |
Device Name: | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM |
Classification | Cabinet, X-ray System |
Applicant | KUB TECHNOLOGIES, INC 543 LONG HILL AVENUE Shelton, CT 06824 |
Contact | Joseph M Azary |
Correspondent | Joseph M Azary KUB TECHNOLOGIES, INC 543 LONG HILL AVENUE Shelton, CT 06824 |
Product Code | MWP |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-03 |
Decision Date | 2007-06-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B619X80L0 | K071233 | 000 |
B619X800 | K071233 | 000 |
B619X420 | K071233 | 000 |
B619X400 | K071233 | 000 |