Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K190800 |
Device Name |
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors |
Applicant |
Cosmed Srl |
Vi dei Piani di Monte Savello 37, Albano Laziale |
Rome,
IT
0041
|
|
Applicant Contact |
Andrea Duca |
Correspondent |
Donawa Lifescience Consulting Srl |
Piazza Albania 10 |
Rome,
IT
00153
|
|
Correspondent Contact |
Roger Gray |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 03/28/2019 |
Decision Date | 02/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|