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FDA 510(k)

VANTAGE INDIRECT OPHTHALMOSCOPE

K-Number: K060822 · 2006-05-23

ApplicantKeeler Instruments, Inc.
Decision Date2006-05-23
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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 2006-05-23 under 510(k) number K060822. 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 VANTAGE INDIRECT OPHTHALMOSCOPE?

VANTAGE INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2006-05-23. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K060822.

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

VANTAGE INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 2006-05-23, under 510(k) number K060822.

Who is the listed applicant for 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 VANTAGE INDIRECT OPHTHALMOSCOPE?

The FDA product code for VANTAGE INDIRECT OPHTHALMOSCOPE is HLI.

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Other records listing Keeler Instruments, Inc. as applicant

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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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