Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K011957 |
Device Name |
IVENT 201 PORTABLE VENTILATOR |
Applicant |
VERSAMED LTD. |
ATIDIM INDUSTRIAL PARK, BLDG 2 |
P.O. BOX 58135 |
TEL-AVIV,
IL
61580
|
|
Applicant Contact |
KEN RAICHMAN |
Correspondent |
VERSAMED LTD. |
ATIDIM INDUSTRIAL PARK, BLDG 2 |
P.O. BOX 58135 |
TEL-AVIV,
IL
61580
|
|
Correspondent Contact |
KEN RAICHMAN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/22/2001 |
Decision Date | 07/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|