Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K150930 |
Device Name |
Deployable Oxygen Generation System-Smaill (DOGS-S) |
Applicant |
AirSep Corporation |
260 Creekside Drive |
Buffalo,
NY
14228
|
|
Applicant Contact |
Peter Weisenborn |
Correspondent |
AirSep Corporation |
260 Creekside Drive |
Buffalo,
NY
14228
|
|
Correspondent Contact |
Ted Vlahopoulos |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 04/06/2015 |
Decision Date | 12/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|