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510(k) K931646

MI-4 VARIABLE SPOT LIGHT by Medical Illumination, Inc. — Product Code KZF

K931646 is an FDA 510(k) premarket notification submitted by Medical Illumination, Inc. for the device "MI-4 VARIABLE SPOT LIGHT". The FDA issued a decision of Substantially Equivalent on August 19, 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
August 19, 1993
Date Received
April 2, 1993
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)
  • K930897 — MI-15 EXAM SURGICAL LIGHT (June 25, 1993)
  • K925710 — M.E.D. LIGHT (June 4, 1993)
  • K922278 — ILLUMINATOR III (March 4, 1993)
  • K922282 — ILLUMINATOR VIII ULTRA/SPOT (March 4, 1993)
  • K922281 — ILLUMINATOR VII MINI/SPOT LIGHT (February 5, 1993)
  • K922277 — ILLUMINATOR II (February 5, 1993)
  • K922280 — ILLUMINATOR VII MINI/LUM 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