Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K991972 |
Device Name |
INFANT FLOW SYSTEM |
Applicant |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
ALEX STENZLER |
Correspondent |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
ALEX STENZLER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/11/1999 |
Decision Date | 08/13/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|