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FDA 510(k)

BLOOD GAS MIXTURE

K-Number: K882941 · 1988-09-09

ApplicantSwisco, Inc.
Decision Date1988-09-09
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS MIXTURE is the device name listed in this FDA 510(k) record. The listed applicant is Swisco, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K882941. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GAS MIXTURE?

BLOOD GAS MIXTURE is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Swisco, Inc.. The 510(k) number is K882941.

When did BLOOD GAS MIXTURE receive FDA 510(k) clearance?

BLOOD GAS MIXTURE received FDA 510(k) clearance on 1988-09-09, under 510(k) number K882941.

Who is the listed applicant for BLOOD GAS MIXTURE?

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

What is the FDA product code for BLOOD GAS MIXTURE?

The FDA product code for BLOOD GAS MIXTURE is CHL.

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 Swisco, 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.

K882942LASER MIXTUREK882817LUNG DIFFUSION GAS MIXTURE

Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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