Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K993268 |
Device Name |
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT |
Applicant |
MALLINCKRODT DAR S.R.L. |
VIA G.BOVE, 2/4/6/8 |
MIRANDOLA (MODENA),
IT
41037
|
|
Applicant Contact |
GIUSEPPE TOMASINI |
Correspondent |
MALLINCKRODT DAR S.R.L. |
VIA G.BOVE, 2/4/6/8 |
MIRANDOLA (MODENA),
IT
41037
|
|
Correspondent Contact |
GIUSEPPE TOMASINI |
Regulation Number | 868.5450
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/1999 |
Decision Date | 04/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|