Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K905697 |
Device Name |
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE |
Applicant |
IMPACT INSTRUMENTATION, INC. |
P.O. BOX 508 |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
LESLIE H SHERMAN |
Correspondent |
IMPACT INSTRUMENTATION, INC. |
P.O. BOX 508 |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
LESLIE H SHERMAN |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 12/24/1990 |
Decision Date | 12/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|