Device Classification Name |
Compressor, Air, Portable
|
510(k) Number |
K031686 |
Device Name |
AEROMIST LT, MODEL HCS15004 |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
ANDREA HAFERKAMP |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
ANDREA HAFERKAMP |
Regulation Number | 868.6250
|
Classification Product Code |
|
Date Received | 06/02/2003 |
Decision Date | 01/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|