Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
510(k) Number |
K071581 |
Device Name |
BACKPACK MEDICAL OXYGEN SYSTEM |
Applicant |
ESSEX CRYOGENICS OF MISSOURI, INC. |
8007 CHIVVIS DR. |
ST. LOUIS,
MO
63123
|
|
Applicant Contact |
ELIZABETH HUNNICUTT |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 06/08/2007 |
Decision Date | 07/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|