Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K053270 |
Device Name |
IVENT 201 |
Applicant |
VERSAMED MEDICAL SYSTEMS, INC. |
2 BLUE HILL PLAZA |
BLDG. 2, 3RD FLOOR |
PEARL RIVER,
NY
10965
|
|
Applicant Contact |
JERRY KORTEN |
Correspondent |
VERSAMED MEDICAL SYSTEMS, INC. |
2 BLUE HILL PLAZA |
BLDG. 2, 3RD FLOOR |
PEARL RIVER,
NY
10965
|
|
Correspondent Contact |
JERRY KORTEN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/23/2005 |
Decision Date | 01/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|