FDA 510(k)

MED-TECH LUNG DIFFUSION MIXTURE

K-Number: K953934 · 1995-09-18

Decision Date1995-09-18

Product CodeBXK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MED-TECH LUNG DIFFUSION 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 1995-09-18 under 510(k) number K953934. The device is classified under product code BXK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MED-TECH LUNG DIFFUSION MIXTURE?

MED-TECH LUNG DIFFUSION MIXTURE is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Medical Technical Gases Inc... The 510(k) number is K953934.

When did MED-TECH LUNG DIFFUSION MIXTURE receive FDA 510(k) clearance?

MED-TECH LUNG DIFFUSION MIXTURE received FDA 510(k) clearance on 1995-09-18, under 510(k) number K953934.

Who is the listed applicant for MED-TECH LUNG DIFFUSION 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 LUNG DIFFUSION MIXTURE?

The FDA product code for MED-TECH LUNG DIFFUSION MIXTURE is BXK.

Related Clinical Trials

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.

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Other records listing Medical Technical Gases Inc.. as applicant

K953935MED-TECH CLINICAL BLOOD GAS K953933MED-TECH LASER GAS MIXTURE

Related Devices (Code: BXK)

K954804LUNG DIFFUSION MIXTURESMittler Supply, Inc.K954803BLOOD GAS MIXTURESMittler Supply, Inc.K954542LUNG DIFFUSION MIXTURELiquid Technology Corp.K952838MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURESStandard Welders Supply Co.K953208MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURESStandard Welders Supply Co.K944998CALIBRATION GASSunox, Inc.

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.