Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K072590 |
Device Name |
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM |
Applicant |
EVENT MEDICAL, INC. |
81 COLUMBIA, SUITE 101 |
ALISO VIEJO,
CA
92656
|
|
Applicant Contact |
ROBERT LUNDBERG |
Correspondent |
EVENT MEDICAL, INC. |
81 COLUMBIA, SUITE 101 |
ALISO VIEJO,
CA
92656
|
|
Correspondent Contact |
ROBERT LUNDBERG |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/14/2007 |
Decision Date | 01/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|