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510(k) K891584

S 22 INSTRUMENT STAND by Carl Zeiss, Inc. — Product Code HRM

K891584 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "S 22 INSTRUMENT STAND". The FDA issued a decision of Substantially Equivalent on June 8, 1989. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), 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
June 8, 1989
Date Received
March 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
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 HRM

  • K932720 — HM-0970 (September 7, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K920641 — ALCON OPERATING MICROSCOPES (October 9, 1992)
  • K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500 (February 3, 1992)
  • K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (April 11, 1989)
  • K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (December 16, 1985)
  • K853855 — XTAL X-150 OPERATING MICROSCOPE (October 15, 1985)
  • K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1 (July 30, 1985)
  • K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (June 3, 1985)
  • K850270 — CORNEAL LIGHT SHIELD (May 31, 1985)

FDA data resources