Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K002881
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K002881
Device Name
Ventilator, Continuous, Facility Use
Applicant
PULMONETIC SYSTEMS, INC.
930 SOUTH MT. VERNON AVE.,
SUITE 100
COLTON, CA 92324-3928 US
Other 510(k) Applications for this Company
Contact
ROBERT HANKINS
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2000
Decision Date
10/11/2000
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact