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FDA 510(k)

OTOSCOPE A-34

K-Number: K950788 · 1995-05-03

ApplicantNeitz Instruments Company, Ltd.
Decision Date1995-05-03
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSCOPE A-34 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 1995-05-03 under 510(k) number K950788. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOSCOPE A-34?

OTOSCOPE A-34 is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K950788.

When did OTOSCOPE A-34 receive FDA 510(k) clearance?

OTOSCOPE A-34 received FDA 510(k) clearance on 1995-05-03, under 510(k) number K950788.

Who is the listed applicant for OTOSCOPE A-34?

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 OTOSCOPE A-34?

The FDA product code for OTOSCOPE A-34 is ERA.

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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-300K951340NEITZ SLIT LAMP SL-H1K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TVK950795STREAK RETINOSCOPE RX-RP

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Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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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