Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K112564 |
Device Name |
QUIXIE NEBULIZER |
Applicant |
ODYSSEY MEDICAL TECHNOLOGIES |
4807 EL CAMINO AVE, |
SUITE C |
CARMICHAEL,
CA
95608
|
|
Applicant Contact |
DAVID PIPER |
Correspondent |
ODYSSEY MEDICAL TECHNOLOGIES |
4807 EL CAMINO AVE, |
SUITE C |
CARMICHAEL,
CA
95608
|
|
Correspondent Contact |
DAVID PIPER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/02/2011 |
Decision Date | 11/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|