Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K003075
Device Classification Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
More FDA Info for this Device
510(K) Number
K003075
Device Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant
MALLINCKRODT, INC.
675 MCDONNELL BLVD.
BLDG. 10-2-N
ST. LOUIS, MO 63134 US
Other 510(k) Applications for this Company
Contact
ANTHONY MULLIN
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2000
Decision Date
12/11/2001
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact