Device Classification Name |
Humidifier, Non-Direct Patient Interface (Home-Use)
|
510(k) Number |
K950116 |
Device Name |
THERASTEAM PERSONAL STEAM INHALER |
Applicant |
KAZ, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
KAZ, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 868.5460
|
Classification Product Code |
|
Date Received | 01/11/1995 |
Decision Date | 02/10/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|