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510(k) K832843

OSCAR COLOUR VISION TESTER by Keeler Instruments, Inc. — Product Code HIT

K832843 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "OSCAR COLOUR VISION TESTER". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
August 22, 1983
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 Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

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)
  • K831074 — OSCAR COLOR VISION TESTER (April 28, 1983)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

FDA data resources