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FDA 510(k)

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)

K-Number: K893172 · 1989-06-05

ApplicantKeeler Instruments, Inc.
Decision Date1989-06-05
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) 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 1989-06-05 under 510(k) number K893172. 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 VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)?

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K893172.

When did VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) receive FDA 510(k) clearance?

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) received FDA 510(k) clearance on 1989-06-05, under 510(k) number K893172.

Who is the listed applicant for VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)?

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 VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)?

The FDA product code for VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) 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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