Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K022684 |
Device Name |
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) |
Applicant |
ESSEX CRYOGENICS OF MISSOURI, INC. |
8007 CHIVVIS DR. |
ST. LOUIS,
MO
63123
|
|
Applicant Contact |
ELIZABETH HUNNICUT |
Correspondent |
ESSEX CRYOGENICS OF MISSOURI, INC. |
8007 CHIVVIS DR. |
ST. LOUIS,
MO
63123
|
|
Correspondent Contact |
ELIZABETH HUNNICUT |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 08/12/2002 |
Decision Date | 09/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|