Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042887
Device Classification Name
Pump, Infusion, Insulin
More FDA Info for this Device
510(K) Number
K042887
Device Name
Pump, Infusion, Insulin
Applicant
DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERGSTRASSE 190
BURGDORF 3401 CH
Other 510(k) Applications for this Company
Contact
Scott Thiel
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
LZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/19/2004
Decision Date
03/18/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact