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510(k) K001223

ACULUX, MODEL AX3001, AX3002 by Aculux — Product Code FQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2000
Date Received
April 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Operating-Room
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Aculux

  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)

Other clearances for product code FQP

  • K993314 — SYNTHES LIGHT GUIDE (December 6, 1999)
  • K781581 — SURGICAL LIGHT 22 SERIES (October 17, 1978)
  • K770812 — HANDLES, LIGHT, SURGICAL, STEOILE (May 23, 1977)
  • K761018 — SURGICAL LIGHT - CHALLENGE 22 SERIES (January 26, 1977)