The following data is part of a premarket notification filed by Qubyx Software Technologies Inc. with the FDA for Dell Up3017 With Qubyx Perfectlum Bundle.
Device ID | K171229 |
510k Number | K171229 |
Device Name: | DELL UP3017 With QUBYX PerfectLum Bundle |
Classification | Display, Diagnostic Radiology |
Applicant | Qubyx Software Technologies Inc. 501 Silverside Road, Suite 105 Wilmington, DE 19809 |
Contact | Marc Leppla |
Correspondent | Marc Leppla Qubyx Software Technologies Inc. 501 Silverside Road, Suite 105 Wilmington, DE 19809 |
Product Code | PGY |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-27 |
Decision Date | 2017-05-26 |
Summary: | summary |