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FDA 510(k)

GAS MIXTURES AS DEVICE COMPONENTS

K-Number: K896412 · 1990-02-01

ApplicantSpectra Gases, Inc.
Decision Date1990-02-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAS MIXTURES AS DEVICE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Gases, Inc.. It received FDA 510(k) clearance on 1990-02-01 under 510(k) number K896412. 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 GAS MIXTURES AS DEVICE COMPONENTS?

GAS MIXTURES AS DEVICE COMPONENTS is a medical device that received FDA 510(k) clearance on 1990-02-01. The listed applicant is Spectra Gases, Inc.. The 510(k) number is K896412.

When did GAS MIXTURES AS DEVICE COMPONENTS receive FDA 510(k) clearance?

GAS MIXTURES AS DEVICE COMPONENTS received FDA 510(k) clearance on 1990-02-01, under 510(k) number K896412.

Who is the listed applicant for GAS MIXTURES AS DEVICE COMPONENTS?

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

What is the FDA product code for GAS MIXTURES AS DEVICE COMPONENTS?

The FDA product code for GAS MIXTURES AS DEVICE COMPONENTS is GEX. This falls under the Gastroenterology category.

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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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