510(k) K021033

STIMUPLEX-DIG-RC NERVE STIMULATOR by B.Braun Medical, Inc. — Product Code BXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2003
Date Received
March 29, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Battery-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type