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510(k) K941869

SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG by The Lighthouse For the Blind, Inc. — Product Code KZF

K941869 is an FDA 510(k) premarket notification submitted by The Lighthouse For the Blind, Inc. for the device "SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG". The FDA issued a decision of Substantially Equivalent on August 3, 1994. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. The Lighthouse For the Blind, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1994
Date Received
April 18, 1994
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 The Lighthouse For the Blind, Inc.

  • K914691 — INDIVIDUAL/LARGE/BELT FIRST AID KITS (January 15, 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)
  • 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)
  • K924447 — VITAPEN (September 27, 1993)

FDA data resources