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510(k) K942233

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM by Carl Zeiss, Inc. — Product Code EPT

K942233 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 1, 1994. 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
July 1, 1994
Date Received
May 9, 1994
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

  • 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)
  • K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (April 30, 1986)
  • 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