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510(k) K971214

KILOWIN by Cadwell Laboratories, Inc. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1998
Date Received
April 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

Other clearances by Cadwell Laboratories, Inc.

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  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)
  • K933808 — EEG CUP ELECTRODE (December 29, 1994)

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