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510(k) K121743

EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN by Sunmed, LLC — Product Code BXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
June 13, 2012
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

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  • K921263 — SUNLITE LARYNGOSCOPE (June 1, 1993)

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  • K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator (March 24, 2015)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • K111985 — MYOGUIDE SYSTEM MODEL 8008 (December 30, 2011)
  • K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR (February 17, 2011)
  • K102084 — STIMPOD NMS450 NERVE STIMULATOR (December 16, 2010)
  • K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR (December 3, 2009)
  • K091155 — ASCEND (September 3, 2009)