Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
510(k) Number |
K113767 |
Device Name |
MOUNTED MEDICAL OXYGEN SYSTEM |
Applicant |
ESSEX INDUSTRIES, INC. |
8007 CHIVVIS DRIVE |
ST. LOUIS,
MO
63123
|
|
Applicant Contact |
KEN SEISE |
Correspondent |
ESSEX INDUSTRIES, INC. |
8007 CHIVVIS DRIVE |
ST. LOUIS,
MO
63123
|
|
Correspondent Contact |
KEN SEISE |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 12/21/2011 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
Yes
|
Combination Product |
No
|
|
|