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510(k) K853720

MOBILE OPERATING TABLE FOR ORL MICROSURGERY by Carl Zeiss, Inc. — Product Code GDC

K853720 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "MOBILE OPERATING TABLE FOR ORL MICROSURGERY". The FDA issued a decision of Substantially Equivalent on October 18, 1985. The device falls under product code GDC (Table, Operating-Room, Electrical), a Class I device regulated under 21 CFR 878.4960. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1985
Date Received
September 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Electrical
Device Class
Class I
Regulation Number
878.4960
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 GDC

  • K971390 — QUANTUM 3080SP SURGICAL TABLE (May 15, 1997)
  • K970807 — MOBILE OPERATING TABLE 1132.01 (March 14, 1997)
  • K964273 — DURA-BOARD ARMBOARD (January 8, 1997)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE (March 28, 1994)
  • K914758 — MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE (December 19, 1991)
  • K915393 — MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE (December 17, 1991)
  • K883613 — OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. (September 15, 1988)
  • K853480 — SKYTRON ELITE 6000 & 6001 SURGICAL TABLES (September 12, 1985)
  • K853535 — TRAUMA TABLE (September 11, 1985)

FDA data resources