|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Masimo SafetyNet
|
Masimo Corporation |
DEN200011 |
|
03/31/2023 |
cobas EBV, cobas EBV/BKV Control Kit, co
|
Roche Molecular Systems, Inc. |
DEN200015 |
|
07/30/2020 |
EndoRotor Device
|
Interscope, Inc |
DEN200016 |
|
12/23/2020 |
Q-Collar
|
Q30 Sports Science, LLC |
DEN200017 |
|
02/26/2021 |
eXciteOSA with remote and eXciteOSA with
|
Signifier Medical Technologies |
DEN200018 |
|
02/05/2021 |
Oxehealth Vital Signs
|
Oxehealth Limited |
DEN200019 |
|
03/26/2021 |
Analytic for Hemodynamic Instability (AH
|
Fifth Eye Inc. |
DEN200022 |
|
03/01/2021 |
EndeavorRx
|
Akili Interactive Labs Inc. |
DEN200026 |
|
06/15/2020 |
Lumenis Stellar M22
|
Lumenis Ltd. |
DEN200028 |
|
02/23/2021 |
Parallel
|
Mahana Therapeutics, Inc. |
DEN200029 |
|
11/25/2020 |