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FDA 510(k)

OSCAR COLOUR VISION TESTER

K-Number: K832843 · 1984-01-04

ApplicantKeeler Instruments, Inc.
Decision Date1984-01-04
Product CodeHIT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OSCAR COLOUR VISION TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1984-01-04 under 510(k) number K832843. The device is classified under product code HIT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCAR COLOUR VISION TESTER?

OSCAR COLOUR VISION TESTER is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K832843.

When did OSCAR COLOUR VISION TESTER receive FDA 510(k) clearance?

OSCAR COLOUR VISION TESTER received FDA 510(k) clearance on 1984-01-04, under 510(k) number K832843.

Who is the listed applicant for OSCAR COLOUR VISION TESTER?

The FDA 510(k) record lists Keeler Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSCAR COLOUR VISION TESTER?

The FDA product code for OSCAR COLOUR VISION TESTER is HIT.

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Other records listing Keeler Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: HIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K903001SLIMCATH (TM)Gynopharma, Inc.K875026ANOMALOSCOPE PLATE TEST - 5 [APT-5]Lkc Technologies, Inc.K873908H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.Richmond Products, Inc.K873911PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15Richmond Products, Inc.K844694TITMUS VISION TESTER IITitmus Optical, Inc.K844365COLOR VISION TESTERSLuneau Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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