Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K042142 |
Device Name |
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S |
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 | 08/09/2004 |
Decision Date | 09/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|