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FDA 510(k)

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE

K-Number: K942104 · 1994-08-04

ApplicantKeeler Instruments, Inc.
Decision Date1994-08-04
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE 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 1994-08-04 under 510(k) number K942104. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEELER VANTAGE INDIRECT OPHTHALMOSCOPE?

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1994-08-04. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K942104.

When did KEELER VANTAGE INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1994-08-04, under 510(k) number K942104.

Who is the listed applicant for KEELER VANTAGE INDIRECT OPHTHALMOSCOPE?

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 KEELER VANTAGE INDIRECT OPHTHALMOSCOPE?

The FDA product code for KEELER VANTAGE INDIRECT OPHTHALMOSCOPE is HLI.

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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: HLI)

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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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