Device Classification Name |
computer, oxygen-uptake
|
510(k) Number |
K190561 |
Device Name |
NICU V'02 |
Applicant |
COSMED Nordic ApS |
Lucernemarken 23 |
Odense,
DK
DK-5260
|
|
Applicant Contact |
Peter Clemensen |
Correspondent |
Wood Burditt Group |
10 E. Scranton Ave., Ste. 201 |
Lake Bluff,
IL
60044
|
|
Correspondent Contact |
H. Carl Jenkins |
Regulation Number | 868.1730
|
Classification Product Code |
|
Date Received | 03/05/2019 |
Decision Date | 09/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|