Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080605
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K080605
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
CURBELL ELECTRONICS INC.
20 CENTRE DR.
ORCHARD PARK, NY 14127 US
Other 510(k) Applications for this Company
Contact
MICHAEL J WINTER
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
03/04/2008
Decision Date
05/05/2008
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