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510(k) K932131

MID LABS TWIN ILLUMINATOR by Medical Instrument Development Laboratories, Inc. — Product Code EQH

K932131 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "MID LABS TWIN ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on April 1, 1994. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1994
Date Received
May 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Medical Instrument Development Laboratories, Inc.

  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)
  • K992943 — VIT ENHANCER (December 10, 1999)
  • K971067 — DIGI-INJECTOR (September 19, 1997)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K934600 — MICRODRIVE (July 27, 1994)
  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)
  • K851610 — COMBINED MVS SYSTEMS (July 22, 1985)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources