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510(k) K112052

CAREFUSION NICOLET EDX by Carefusion 209, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2012
Date Received
July 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Carefusion 209, Inc.

  • K120979 — CAREFUSION NICOLET EDX (April 25, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)
  • K103140 — NICOLET WIRELESS EEG (April 8, 2011)

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