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510(k) K841731

BRIMFIELD FIBEROPTIC LIGHT SCOURCE by Brimfield Scientific Instruments — Product Code EQH

K841731 is an FDA 510(k) premarket notification submitted by Brimfield Scientific Instruments for the device "BRIMFIELD FIBEROPTIC LIGHT SCOURCE". The FDA issued a decision of Substantially Equivalent on July 16, 1984. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Brimfield Scientific Instruments has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1984
Date Received
April 26, 1984
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 Brimfield Scientific Instruments

  • K852042 — BRIMFIELD CANNULATED BLADE HOLDER (June 11, 1985)
  • K843135 — BRIMFIELD CANNULATED MAGNETIC RETRIEVER (September 26, 1984)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K832147 — CIRCUT 1 (July 26, 1983)

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)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

FDA data resources