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FDA 510(k)

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

K-Number: K994346 · 2000-02-01

ApplicantSendx Medical, Inc.
Decision Date2000-02-01
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS 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 2000-02-01 under 510(k) number K994346. 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 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM?

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Sendx Medical, Inc.. The 510(k) number is K994346.

When did ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM receive FDA 510(k) clearance?

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM received FDA 510(k) clearance on 2000-02-01, under 510(k) number K994346.

Who is the listed applicant for ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS 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 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM?

The FDA product code for ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM is CHL.

Related Clinical Trials

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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.

K080370ABL 80 CO-OX SYSTEMK051804ABL80 FLEX ANALYZERK973742SENDX 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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