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FDA 510(k)

OPMI TWINER SURGICAL MICROSCOPE

K-Number: K983868 · 1999-01-29

ApplicantCarl Zeiss, Inc.
Decision Date1999-01-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPMI TWINER SURGICAL MICROSCOPE 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 1999-01-29 under 510(k) number K983868. 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 OPMI TWINER SURGICAL MICROSCOPE?

OPMI TWINER SURGICAL MICROSCOPE is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K983868.

When did OPMI TWINER SURGICAL MICROSCOPE receive FDA 510(k) clearance?

OPMI TWINER SURGICAL MICROSCOPE received FDA 510(k) clearance on 1999-01-29, under 510(k) number K983868.

Who is the listed applicant for OPMI TWINER SURGICAL MICROSCOPE?

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 OPMI TWINER SURGICAL MICROSCOPE?

The FDA product code for OPMI TWINER SURGICAL MICROSCOPE is GEX. This falls under the Gastroenterology category.

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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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