Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K132205 |
Device Name |
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM |
Applicant |
INOVA LABS, INC. |
2800 PLEASANT HILL RD., SUITE 175 |
SUITE 175 |
PLEASANT HILL,
CA
94523
|
|
Applicant Contact |
PAMELA M BUCKMAN |
Correspondent |
INOVA LABS, INC. |
2800 PLEASANT HILL RD., SUITE 175 |
SUITE 175 |
PLEASANT HILL,
CA
94523
|
|
Correspondent Contact |
PAMELA M BUCKMAN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 07/16/2013 |
Decision Date | 06/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|