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FDA 510(k)

O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP

K-Number: K871100 · 1987-04-21

ApplicantMatheson Gas Products, Inc.
Decision Date1987-04-21
Product CodeBXK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP is the device name listed in this FDA 510(k) record. The listed applicant is Matheson Gas Products, Inc.. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K871100. 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 O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP?

O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Matheson Gas Products, Inc.. The 510(k) number is K871100.

When did O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP receive FDA 510(k) clearance?

O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871100.

Who is the listed applicant for O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP?

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

What is the FDA product code for O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP?

The FDA product code for O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Matheson Gas Products, 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.

K882516THREE-COMPONENT MEDICAL LASER GAS MIXTURESK8711010.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.K871103O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.PK871102O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF

Related Devices (Code: BXK)

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.

K954803BLOOD GAS MIXTURESMittler Supply, Inc.K954804LUNG DIFFUSION MIXTURESMittler Supply, Inc.K954542LUNG DIFFUSION MIXTURELiquid Technology Corp.K952838MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURESStandard Welders Supply Co.K953934MED-TECH LUNG DIFFUSION MIXTUREMedical Technical Gases Inc..K953208MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURESStandard Welders Supply Co.

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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