| Device Classification Name |
Conserver, Oxygen
|
| 510(k) Number |
K010389 |
| Device Name |
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 |
| 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 | 868.5905 |
| Classification Product Code |
|
| Date Received | 02/09/2001 |
| Decision Date | 03/23/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|