Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K013472 |
Device Name |
TOTAL O2 |
Applicant |
CHAD THERAPEUTICS, INC. |
21622 PLUMMER ST. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
KEVIN MCCULLOH |
Correspondent |
CHAD THERAPEUTICS, INC. |
21622 PLUMMER ST. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
KEVIN MCCULLOH |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 10/18/2001 |
Decision Date | 11/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|