Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K091238 |
Device Name |
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ |
Applicant |
IMPACT INSTRUMENTATION, INC. |
27 FAIRFIELD PL. |
WEST CALDWELL,
NJ
07006 -0508
|
|
Applicant Contact |
LESLIE H SHERMAN |
Correspondent |
IMPACT INSTRUMENTATION, INC. |
27 FAIRFIELD PL. |
WEST CALDWELL,
NJ
07006 -0508
|
|
Correspondent Contact |
LESLIE H SHERMAN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/27/2009 |
Decision Date | 08/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|