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FDA 510(k) Application Details - K052313
Device Classification Name
Stimulator, Nerve, Battery-Powered
More FDA Info for this Device
510(K) Number
K052313
Device Name
Stimulator, Nerve, Battery-Powered
Applicant
STOCKERT GMBH
BOETZINGER STRASSE 72
FREIBURG, B-W D-79111 DE
Other 510(k) Applications for this Company
Contact
DOMINIKA SCHULER
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
BXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/25/2005
Decision Date
11/17/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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