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510(k) K961171

HUMPHREY OCT SCANNER by Carl Zeiss, Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1996
Date Received
March 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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  • 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)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)
  • K931478 — ZEISS OPMI L STEREO-LAPAROSCOPE (September 28, 1994)

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