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510(k) K942926

NEURO-AIDE by Burke Neutech, Inc. — Product Code GWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1994
Date Received
June 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pinwheel
Device Class
Class I
Regulation Number
882.1750
Review Panel
NE
Submission Type

Other clearances by Burke Neutech, Inc.

  • K955326 — SPORTS CONTRAST THERAPY SYSTEM ST 7000 (April 10, 1996)
  • K952117 — EPILATOR (October 19, 1995)
  • K943497 — CONTRAST 7000 THERAPY SYSTEM (June 7, 1995)
  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • K940160 — TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (May 27, 1994)
  • K926151 — LSI6000 THERMAL THERAPY SYSTEM (May 26, 1993)

Other clearances for product code GWY

  • K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
  • K871167 — SENSITESTER (April 1, 1987)
  • K851749 — 1-380 PINWHEEL (WARTENBERG) (June 13, 1985)
  • K780422 — PINWHEEL (April 4, 1978)