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FDA 510(k)

STREAK RETINOSCOPE RX-2

K-Number: K950790 · 1995-03-22

ApplicantNeitz Instruments Company, Ltd.
Decision Date1995-03-22
Product CodeHKL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STREAK RETINOSCOPE RX-2 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 1995-03-22 under 510(k) number K950790. The device is classified under product code HKL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREAK RETINOSCOPE RX-2?

STREAK RETINOSCOPE RX-2 is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K950790.

When did STREAK RETINOSCOPE RX-2 receive FDA 510(k) clearance?

STREAK RETINOSCOPE RX-2 received FDA 510(k) clearance on 1995-03-22, under 510(k) number K950790.

Who is the listed applicant for STREAK RETINOSCOPE RX-2?

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-2?

The FDA product code for STREAK RETINOSCOPE RX-2 is HKL.

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Other records listing Neitz Instruments Company, Ltd. 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.

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: HKL)

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.

K001111PANORET, MODEL 1000ACmt Medical Technologies, Ltd.K950789STREAK RETINOSCOPE RX-1Neitz Instruments Company, Ltd.K893171VISTA STREAK RETINOSCOPE (AC-POWERED)Keeler Instruments, Inc.K812764KOI BLUE FIELD ENTOPTOSCOPEKoi, Inc.K800238MOIRE FRINGE VISOMETER AFTER LOTMARHagg-Streit Service, Inc.

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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