Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K101660
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K101660
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
KEPLER MEDTEC
200 Homer Ave
Ashland, MA 01721 US
Other 510(k) Applications for this Company
Contact
F. DAVID ROTHKOPF
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/14/2010
Decision Date
08/11/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact