Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K060374
Device Classification Name
Amplifier, Physiological Signal
More FDA Info for this Device
510(K) Number
K060374
Device Name
Amplifier, Physiological Signal
Applicant
TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN, CO 80439 US
Other 510(k) Applications for this Company
Contact
DAVID W WAGNER
Other 510(k) Applications for this Contact
Regulation Number
882.1835
More FDA Info for this Regulation Number
Classification Product Code
GWL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2006
Decision Date
05/30/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact