The following data is part of a premarket notification filed by Kub Technologies, Inc. with the FDA for Kubtec Mozart (xpert42).
Device ID | K183624 |
510k Number | K183624 |
Device Name: | Kubtec Mozart (Xpert42) |
Classification | Cabinet, X-ray System |
Applicant | KUB Technologies, Inc. 111 Research Drive Stratford, CT 06615 |
Contact | Chester Lowe |
Correspondent | Chester Lowe KUB Technologies, Inc. 111 Research Drive Stratford, CT 06615 |
Product Code | MWP |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-26 |
Decision Date | 2019-06-20 |