Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K060647 |
Device Name |
LTV 1200 VENTILATOR |
Applicant |
PULMONETIC SYSTEMS, INC. |
17400 MEDINA ROAD |
SUITE 100 |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
ROBERT SAMEC |
Correspondent |
PULMONETIC SYSTEMS, INC. |
17400 MEDINA ROAD |
SUITE 100 |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
ROBERT SAMEC |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/13/2006 |
Decision Date | 05/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|