Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K972657 |
Device Name |
ULTRAMIST 2000 |
Applicant |
TEXAS MEDICAL INDUSTRIES, INC. |
1409 INDUSTRIAL PARK |
ROYSE CITY,
TX
75189
|
|
Applicant Contact |
STEVE HARLOW |
Correspondent |
TEXAS MEDICAL INDUSTRIES, INC. |
1409 INDUSTRIAL PARK |
ROYSE CITY,
TX
75189
|
|
Correspondent Contact |
STEVE HARLOW |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/15/1997 |
Decision Date | 02/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|