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FDA 510(k)

STREAK RETINOSCOPE RX-3A

K-Number: K950792 · 1995-03-28

ApplicantNeitz Instruments Company, Ltd.
Decision Date1995-03-28
Product CodeHKM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STREAK RETINOSCOPE RX-3A 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 1995-03-28 under 510(k) number K950792. The device is classified under product code HKM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREAK RETINOSCOPE RX-3A?

STREAK RETINOSCOPE RX-3A is a medical device that received FDA 510(k) clearance on 1995-03-28. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K950792.

When did STREAK RETINOSCOPE RX-3A receive FDA 510(k) clearance?

STREAK RETINOSCOPE RX-3A received FDA 510(k) clearance on 1995-03-28, under 510(k) number K950792.

Who is the listed applicant for STREAK RETINOSCOPE RX-3A?

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 STREAK RETINOSCOPE RX-3A?

The FDA product code for STREAK RETINOSCOPE RX-3A is HKM.

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Other records listing Neitz Instruments Company, Ltd. as applicant

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K972440CATARACTSCREENER CT - SK951341NEITZ SLIT LAMP SL-H2K951337FIBER HEAD LIGHT FH-300K950788OTOSCOPE A-34K951340NEITZ SLIT LAMP SL-H1K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

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Related Devices (Code: HKM)

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.

K964338RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOTRudolf Riester GmbH & Co. KGK950795STREAK RETINOSCOPE RX-RPNeitz Instruments Company, Ltd.K950793SPOT RETINOSCOPE RX-3SPNeitz Instruments Company, Ltd.K950791STREAK RETINOSCOPE RX-3Neitz Instruments Company, Ltd.K950794STREAK RETINOSCOPE RX-RCNeitz Instruments Company, Ltd.K840840GENERATED RETINAL REFLEX IMAGERY SYSElectro Optical Instruments

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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