Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K151361 |
Device Name |
Nox RIP Belts & Cables |
Applicant |
NOX MEDICAL ehf |
KATRINARTUNI 2 |
REYKJAVIK,
IS
105
|
|
Applicant Contact |
KOLBRUN E OTTOSDOTTIR |
Correspondent |
NOX MEDICAL ehf |
KATRINARTUNI 2 |
REYKJAVIK,
IS
105
|
|
Correspondent Contact |
KOLBRUN E OTTOSDOTTIR |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/21/2015 |
Decision Date | 11/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|