Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K043238 |
Device Name |
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES |
Applicant |
EMG TECHNOLOGY CO., LTD. |
914 WEST PATAPSCO AVE. |
BALTIMORE,
MD
21230
|
|
Applicant Contact |
LEONARD FRIER |
Correspondent |
EMG TECHNOLOGY CO., LTD. |
914 WEST PATAPSCO AVE. |
BALTIMORE,
MD
21230
|
|
Correspondent Contact |
LEONARD FRIER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/22/2004 |
Decision Date | 07/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|