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510(k) K010087

XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP by Excel Tech. , Ltd. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2001
Date Received
January 11, 2001
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 Excel Tech. , Ltd.

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  • K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (April 21, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (October 28, 2005)
  • K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (August 17, 2005)
  • K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054 (September 16, 2004)
  • K042150 — XLTEK TREX MODEL#10309 (August 27, 2004)
  • K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (August 6, 2004)
  • K040360 — EMU128S, MODEL EX-NW-128S (March 12, 2004)

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