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FDA 510(k)

ABL 80 CO-OX SYSTEM

K-Number: K080370 · 2008-07-31

ApplicantSendx Medical, Inc.
Decision Date2008-07-31
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL 80 CO-OX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sendx Medical, Inc.. It received FDA 510(k) clearance on 2008-07-31 under 510(k) number K080370. 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 ABL 80 CO-OX SYSTEM?

ABL 80 CO-OX SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-31. The listed applicant is Sendx Medical, Inc.. The 510(k) number is K080370.

When did ABL 80 CO-OX SYSTEM receive FDA 510(k) clearance?

ABL 80 CO-OX SYSTEM received FDA 510(k) clearance on 2008-07-31, under 510(k) number K080370.

Who is the listed applicant for ABL 80 CO-OX SYSTEM?

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

What is the FDA product code for ABL 80 CO-OX SYSTEM?

The FDA product code for ABL 80 CO-OX SYSTEM 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 Sendx Medical, 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.

K051804ABL80 FLEX ANALYZERK994346ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMK973742SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

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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