Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K031179 |
Device Name |
TAGA VELOCITY HUMIDIFIER |
Applicant |
TAGA MEDICAL TECHNOLOGIES, INC. |
34675 VOKES DR STE 105 |
EASTLAKE,
OH
44095
|
|
Applicant Contact |
GARY AUSTIN |
Correspondent |
TAGA MEDICAL TECHNOLOGIES, INC. |
34675 VOKES DR STE 105 |
EASTLAKE,
OH
44095
|
|
Correspondent Contact |
GARY AUSTIN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 04/15/2003 |
Decision Date | 07/17/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|