|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Neurolutions Upper Extremity Rehabilitat
|
Neurolutions, Inc. |
DEN200046 |
|
04/23/2021 |
GI Genius
|
Cosmo Artificial Intelligence - AI, LTD |
DEN200055 |
|
04/09/2021 |
Gili Pro BioSensor (also known as “Gili
|
ContinUse Biometrics Ltd. |
DEN200038 |
|
04/01/2021 |
Portable Neuromodulation Stimulator (PoN
|
Helius Medical, Inc. |
DEN200050 |
|
03/26/2021 |
Oxehealth Vital Signs
|
Oxehealth Limited |
DEN200019 |
|
03/26/2021 |
BioFire Respiratory Panel 2.1 (RP2.1)
|
Biofire Diagnostics, LLC |
DEN200031 |
|
03/17/2021 |
ClearUP Sinus Relief
|
Tivic Health Systems Inc. |
DEN200006 |
|
03/05/2021 |
Analytic for Hemodynamic Instability (AH
|
Fifth Eye Inc. |
DEN200022 |
|
03/01/2021 |
Hominis Surgical System
|
Memic Innovative Surgery Ltd. |
DEN190022 |
|
02/26/2021 |
Q-Collar
|
Q30 Sports Science, LLC |
DEN200017 |
|
02/26/2021 |