Home / 510(k) Clearances / K860811

510(k) K860811

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S by Carl Zeiss, Inc. — Product Code EPT

K860811 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "ZEISS VOICE CONTROL SYSTEM FOR OPMI'S". The FDA issued a decision of Substantially Equivalent on April 30, 1986. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Carl Zeiss, Inc.

  • K013402 — VISULAS 532S (November 14, 2001)
  • K003885 — VISULAS YAG II (February 22, 2001)
  • K993357 — IOLMASTER (March 20, 2000)
  • K983868 — OPMI TWINER SURGICAL MICROSCOPE (January 29, 1999)
  • K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (April 23, 1997)
  • K961380 — CPC PROBE (March 17, 1997)
  • K961171 — HUMPHREY OCT SCANNER (June 21, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE (November 18, 1993)
  • K933310 — MICRINS CONTRAST BACKGROUND MATERIAL (August 19, 1993)
  • K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (September 20, 1990)
  • K883581 — OPMI CS (September 13, 1988)
  • K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM (June 23, 1988)
  • K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (March 25, 1985)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K823011 — VC III (November 8, 1982)
  • K822561 — MICROSCOPE (September 14, 1982)

FDA data resources