Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K121260 |
Device Name |
TROOPER OXYGEN CONCENTRATOR |
Applicant |
VBOX, INC. |
2342 EAST COUNTY |
ROAD J |
WHITE BEAR LAKE,
MN
55110
|
|
Applicant Contact |
THEODORE JAGGER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 04/26/2012 |
Decision Date | 09/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|