Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K043269
Device Classification Name
More FDA Info for this Device
510(K) Number
K043269
Device Name
Lysus Infusion System
Applicant
EKOS CORP.
22030 20TH AVENUE S.E.
SUITE 101
BOTHELL, WA 98021 US
Other 510(k) Applications for this Company
Contact
JOCELYN KERSTEN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2004
Decision Date
12/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact