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510(k) K841099

OCTOPUS 500/500E by Cilco, Inc. — Product Code HPT

K841099 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "OCTOPUS 500/500E". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Automatic, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Cilco, Inc.

  • K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (May 2, 1986)
  • K854969 — CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (February 27, 1986)
  • K844249 — K-SOL (April 30, 1985)
  • K843319 — CILCO I/A SURGICAL PACK (February 14, 1985)
  • K843992 — CILCOR OPHTHALMIC INSTRUMENTS (November 21, 1984)
  • K843447 — CILCO DIAMOND KNIFE (October 5, 1984)
  • K840475 — CYSTOTOME, 140-S (April 5, 1984)
  • K832405 — OPTHALMIC ENDOSCOPE (November 21, 1983)
  • K827371 — CILCO ASCAN (July 9, 1982)
  • K820933 — CILCO I/A HANDPIECE (June 14, 1982)

Other clearances for product code HPT

  • K092187 — MAIA, MODEL 1 (May 27, 2010)
  • K093213 — GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (March 12, 2010)
  • K091579 — FORESEE HOME (December 23, 2009)
  • K063310 — TRUEFIELD ANALYZER (August 2, 2007)
  • K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (April 29, 2005)
  • K023623 — NOVAVISION, MODEL 2.0 (April 22, 2003)
  • K971156 — KASHA VISUAL FIELD SYSTEM (May 28, 1997)
  • K961090 — AUTOMATIC VISUAL FIELD PLOTTER AP-125 (June 17, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K954037 — FIELD TREND (November 17, 1995)

FDA data resources