The following data is part of a premarket notification filed by Nico.lab B.v. with the FDA for Halo.
Device ID | K211788 |
510k Number | K211788 |
Device Name: | HALO |
Classification | Radiological Computer-assisted Triage And Notification Software |
Applicant | Nico.Lab B.V. Paasheuvelweg 25 Amsterdam, NL 1105 Bp |
Contact | Merel Boers |
Correspondent | Ruojuan Zhang MD Squared B.V. High Tech Campus 29 Eindhoven, NL 5656 Ae |
Product Code | QAS |
CFR Regulation Number | 892.2080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-09 |
Decision Date | 2021-07-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HALO 98454522 not registered Live/Pending |
Halo, Inc. 2024-03-18 |
HALO 98404978 not registered Live/Pending |
Prophetic, Inc. 2024-02-14 |
HALO 98398702 not registered Live/Pending |
Halo Water Systems, LLC 2024-02-08 |
HALO 98381032 not registered Live/Pending |
CenTex Aerospace, Inc. 2024-01-29 |
HALO 98363520 not registered Live/Pending |
Grace O'Donnell 2024-01-18 |
HALO 98342492 not registered Live/Pending |
REJOICE INTERNATIONAL CORP. 2024-01-04 |
HALO 98317855 not registered Live/Pending |
American Baitworks Co. 2023-12-16 |
HALO 98312564 not registered Live/Pending |
Maars Holding B.V. 2023-12-13 |
HALO 98294381 not registered Live/Pending |
NEXALIN TECHNOLOGY, INC. 2023-12-01 |
HALO 98230495 not registered Live/Pending |
Halo Technologies, Inc 2023-10-19 |
HALO 98177894 not registered Live/Pending |
Storyteller Overland, LLC 2023-09-13 |
HALO 98124486 not registered Live/Pending |
Down-Lite International, Inc. 2023-08-09 |