Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K162515 |
Device Name |
COSMED K5 Wearable Metabolic Technology |
Applicant |
COSMED S.r.l. |
Via dei Piani di Monte Savello, 37 |
Pavona di Albano Rome,
IT
00041
|
|
Applicant Contact |
Andrea Duca |
Correspondent |
Donawa Lifescience Consulting Srl |
Piazza Albania 10 |
Rome,
IT
00153
|
|
Correspondent Contact |
Roger Gray |
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 09/08/2016 |
Decision Date | 06/20/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|