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FDA 510(k)

ZEISS MULTI YAG LASER

K-Number: K920967 · 1992-07-08

ApplicantCarl Zeiss, Inc.
Decision Date1992-07-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZEISS MULTI YAG LASER 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 1992-07-08 under 510(k) number K920967. 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 MULTI YAG LASER?

ZEISS MULTI YAG LASER is a medical device that received FDA 510(k) clearance on 1992-07-08. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K920967.

When did ZEISS MULTI YAG LASER receive FDA 510(k) clearance?

ZEISS MULTI YAG LASER received FDA 510(k) clearance on 1992-07-08, under 510(k) number K920967.

Who is the listed applicant for ZEISS MULTI YAG LASER?

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 MULTI YAG LASER?

The FDA product code for ZEISS MULTI YAG LASER 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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