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510(k) K810700

CHROMOPS FM-100 COLOR VISION TESTER by Visidyne Corp. — Product Code HIT

K810700 is an FDA 510(k) premarket notification submitted by Visidyne Corp. for the device "CHROMOPS FM-100 COLOR VISION TESTER". The FDA issued a decision of Substantially Equivalent on April 10, 1981. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Visidyne Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1981
Date Received
March 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Color Vision
Device Class
Class I
Regulation Number
886.1170
Review Panel
OP
Submission Type

Other clearances by Visidyne Corp.

  • K811316 — TRISCAN, MODELS 38,40,41,43 & 45 (July 2, 1981)
  • K810699 — PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM (June 9, 1981)

Other clearances for product code HIT

  • K903001 — SLIMCATH (TM) (June 25, 1991)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K844694 — TITMUS VISION TESTER II (January 22, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K832843 — OSCAR COLOUR VISION TESTER (January 4, 1984)
  • K831074 — OSCAR COLOR VISION TESTER (April 28, 1983)

FDA data resources