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510(k) K922278

ILLUMINATOR III by Medical Illumination, Inc. — Product Code KZF

K922278 is an FDA 510(k) premarket notification submitted by Medical Illumination, Inc. for the device "ILLUMINATOR III". The FDA issued a decision of Substantially Equivalent on March 4, 1993. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Medical Illumination, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1993
Date Received
May 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Medical Examination, Ac Powered
Device Class
Class I
Regulation Number
880.6320
Review Panel
HO
Submission Type

Other clearances by Medical Illumination, Inc.

  • K931026 — MI-5 DIAGNOSTIC LIGHT (August 19, 1993)
  • K931646 — MI-4 VARIABLE SPOT LIGHT (August 19, 1993)
  • K930897 — MI-15 EXAM SURGICAL LIGHT (June 25, 1993)
  • K925710 — M.E.D. LIGHT (June 4, 1993)
  • K922282 — ILLUMINATOR VIII ULTRA/SPOT (March 4, 1993)
  • K922280 — ILLUMINATOR VII MINI/LUM LIGHT (February 5, 1993)
  • K922277 — ILLUMINATOR II (February 5, 1993)
  • K922281 — ILLUMINATOR VII MINI/SPOT LIGHT (February 5, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)

Other clearances for product code KZF

  • K954943 — NEVOSCOPE (March 27, 1996)
  • K952835 — WELCH ALLYN VIDEO EPISCOPE (September 22, 1995)
  • K945507 — H 5100, H 5200, H 5300 (December 9, 1994)
  • K941869 — SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (August 3, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K940284 — MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (February 28, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K935832 — CHROMOPHARE (February 3, 1994)
  • K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT (January 28, 1994)
  • K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS (December 2, 1993)

FDA data resources