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FDA 510(k)

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

K-Number: K951338 · 1995-04-07

Decision Date1995-04-07
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV 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 1995-04-07 under 510(k) number K951338. 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 INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV?

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV is a medical device that received FDA 510(k) clearance on 1995-04-07. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K951338.

When did INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV receive FDA 510(k) clearance?

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV received FDA 510(k) clearance on 1995-04-07, under 510(k) number K951338.

Who is the listed applicant for INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV?

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 INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV?

The FDA product code for INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV is HLI.

Related Clinical Trials

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.

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.

View all 24 devices →

Related Devices (Code: HLI)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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