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FDA 510(k)

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC

K-Number: K942715 · 1994-08-05

ApplicantNeitz Instruments Company, Ltd.
Decision Date1994-08-05
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC is the device name listed in this FDA 510(k) record. The listed applicant is Neitz Instruments Company, Ltd.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K942715. 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 NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC?

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K942715.

When did NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC receive FDA 510(k) clearance?

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC received FDA 510(k) clearance on 1994-08-05, under 510(k) number K942715.

Who is the listed applicant for NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC?

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

What is the FDA product code for NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC?

The FDA product code for NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC is 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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