Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K893622 |
Device Name |
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. |
Applicant |
PREEMICARE CORP. |
3300 WALNUT BEND LN. |
HOUSTON,
TX
77042
|
|
Applicant Contact |
CHARLES BOYD |
Correspondent |
PREEMICARE CORP. |
3300 WALNUT BEND LN. |
HOUSTON,
TX
77042
|
|
Correspondent Contact |
CHARLES BOYD |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/11/1989 |
Decision Date | 01/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|