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FDA 510(k)

OPMILAS CO2-L

K-Number: K894393 · 1989-07-27

ApplicantCarl Zeiss, Inc.
Decision Date1989-07-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPMILAS CO2-L 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 1989-07-27 under 510(k) number K894393. 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 OPMILAS CO2-L?

OPMILAS CO2-L is a medical device that received FDA 510(k) clearance on 1989-07-27. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K894393.

When did OPMILAS CO2-L receive FDA 510(k) clearance?

OPMILAS CO2-L received FDA 510(k) clearance on 1989-07-27, under 510(k) number K894393.

Who is the listed applicant for OPMILAS CO2-L?

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 OPMILAS CO2-L?

The FDA product code for OPMILAS CO2-L 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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