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FDA 510(k) Application Details - K110010
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K110010
Device Name
Electrode, Depth
Applicant
BLACKROCK MICROSYSTEMS, INC
391 CHIPETA WAY
SUITE G
SALT LAKE CITY, UT 84108 US
Other 510(k) Applications for this Company
Contact
JERRY ALPERIN
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2011
Decision Date
02/09/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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