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FDA 510(k)

ZEISS LASER INDIRECT OPHTHALMOSCOPE

K-Number: K924588 · 1993-07-09

ApplicantCarl Zeiss, Inc.
Decision Date1993-07-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZEISS LASER INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K924588. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEISS LASER INDIRECT OPHTHALMOSCOPE?

ZEISS LASER INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K924588.

When did ZEISS LASER INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

ZEISS LASER INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1993-07-09, under 510(k) number K924588.

Who is the listed applicant for ZEISS LASER INDIRECT OPHTHALMOSCOPE?

The FDA 510(k) record lists Carl Zeiss, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEISS LASER INDIRECT OPHTHALMOSCOPE?

The FDA product code for ZEISS LASER INDIRECT OPHTHALMOSCOPE is GEX. This falls under the Gastroenterology category.

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Other records listing Carl Zeiss, Inc. as applicant

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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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