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FDA 510(k)

MED-TECH LASER GAS MIXTURE

K-Number: K953933 · 1995-09-01

ApplicantMedical Technical Gases Inc..
Decision Date1995-09-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MED-TECH LASER GAS MIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technical Gases Inc... It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K953933. 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 MED-TECH LASER GAS MIXTURE?

MED-TECH LASER GAS MIXTURE is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Medical Technical Gases Inc... The 510(k) number is K953933.

When did MED-TECH LASER GAS MIXTURE receive FDA 510(k) clearance?

MED-TECH LASER GAS MIXTURE received FDA 510(k) clearance on 1995-09-01, under 510(k) number K953933.

Who is the listed applicant for MED-TECH LASER GAS MIXTURE?

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

What is the FDA product code for MED-TECH LASER GAS MIXTURE?

The FDA product code for MED-TECH LASER GAS MIXTURE is GEX. This falls under the Gastroenterology category.

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Other records listing Medical Technical Gases Inc.. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953935MED-TECH CLINICAL BLOOD GASK953934MED-TECH LUNG DIFFUSION MIXTURE

Related Devices (Code: GEX)

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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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