Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K083828
Device Classification Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
More FDA Info for this Device
510(K) Number
K083828
Device Name
Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant
TRANSOMA
119 14TH STREET NW
ST. PAUL, MN 55112 US
Other 510(k) Applications for this Company
Contact
LISA STONE
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2008
Decision Date
02/11/2009
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