510(k) K061172

PAJUNK MULTISTIM SENSOR NERVE STIMULATORS by PAJUNK GmbH Medizintechnologie — Product Code BXN

K061172 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "PAJUNK MULTISTIM SENSOR NERVE STIMULATORS". The FDA issued a decision of Substantially Equivalent on October 17, 2006. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2006
Date Received
April 27, 2006
Clearance Type
Traditional
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