Device Classification Name |
set, tubing and support, ventilator (w harness)
|
510(k) Number |
K860659 |
Device Name |
END TIDAL CO2 SAMPLING CIRCUIT |
Applicant |
LIFE DESIGN SYSTEMS, INC. |
11017 WEST LAYTON AVE. |
MILWAUKEE,
WI
53228
|
|
Applicant Contact |
GILBERT M KIRK |
Correspondent |
LIFE DESIGN SYSTEMS, INC. |
11017 WEST LAYTON AVE. |
MILWAUKEE,
WI
53228
|
|
Correspondent Contact |
GILBERT M KIRK |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 02/24/1986 |
Decision Date | 04/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|