Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K183089 |
Device Name |
Air Next |
Applicant |
NuvoAir AB |
17D Riddargatan |
stockholm,
SE
11457
|
|
Applicant Contact |
max ladow |
Correspondent |
Smith Associates |
1468 Harwell Ave |
crofton,
MD
21114
|
|
Correspondent Contact |
yolanda smith |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/06/2018 |
Decision Date | 01/02/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|