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510(k) K120979

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2012
Date Received
April 2, 2012
Clearance Type
Special
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.

  • K112052 — CAREFUSION NICOLET EDX (March 15, 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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