Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K092135 |
Device Name |
MODIFICATION TO IVENT 101 |
Applicant |
VERSAMED MEDICAL SYSTEMS LTD. |
PO BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Applicant Contact |
ADRIANNE LENZ |
Correspondent |
VERSAMED MEDICAL SYSTEMS LTD. |
PO BOX 7550 |
MADISON,
WI
53707 -7550
|
|
Correspondent Contact |
ADRIANNE LENZ |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/15/2009 |
Decision Date | 11/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|