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510(k) K933564

SKYTRON EXAM LIGHT by Skytron, Div. the Kmw Group, Inc. — Product Code KZF

K933564 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON EXAM LIGHT". The FDA issued a decision of Substantially Equivalent on February 10, 1994. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
July 22, 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 Skytron, Div. the Kmw Group, Inc.

  • K071698 — AURORA LED SERIES SURGICAL LIGHTS (July 6, 2007)
  • K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES (November 13, 2002)
  • K002463 — STELLAR (November 8, 2000)
  • K992090 — MILLENNIUM GOLD (September 8, 1999)
  • K950192 — SKYTRON SKYBOOM SERIES (April 3, 1995)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K926045 — SKYTRON LIFE ISLAND 21 (July 27, 1993)
  • K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS (February 20, 1992)
  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)
  • K900211 — SKYTRON UNIVERSE SERIES SURGICAL LIGHTS (March 19, 1990)

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)
  • 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)
  • K924447 — VITAPEN (September 27, 1993)

FDA data resources