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510(k) K854751

ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE by Aspen Laboratories, Inc. — Product Code EQH

K854751 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1986
Date Received
November 26, 1985
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 Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

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